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Adverse Event Report

COCHLEAR LTD. NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS 22 CHANNEL COCHLEAR IMPLANT FOR ADULTS   back to search results
Model Number CI22M
Event Date 04/07/1998
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The patient reported noticing blood in her external auditory canal. The physician who did an otoscopic exam noted that the lead wire of the electrode array had extruded through the tympanic membrane. The surgeon is considering surgical repair of the tympanic membrane. No date has been set. The patient is using and doing well with her implant.

 
Manufacturer Narrative

The pt is doing well with her reimplanted device. This is the final report. On 10/28/1996, pt experience overstimulation during intial programming sessions after unplugging his processor during mapping. 10/29/1996, equipment problem report was completed for processor # 343095 and processor was replaced (replacement processor #340094) after that pt refused to wear his processor even though t and c levels were reset to very low levels (t=1; c=10 current levels). Pt was then managed by cochlear implant centre in basel at parents request, until 6/1997 when family relocated to england. Since then pt has been seen at hosp and currently under the facility, with reported progressive loss of electrode function. He became non user approx 20 months post implant. Integrity test: pt's external equipment was checked and found to be working. Integrity test was performed with cochlear's own test processor. Automated integrity test for ci22 protocol was used. Continuity and rf parameter tests were satisfactory. Intermittent results were obtained during electrode tests. No pulse recorded during amplitude growth test. Pulse width test / rate and range and complex stimuli test were within expected limits. Visual inspection: electrode array was observed to be severed between helix and stiffening rings. Silastic at tip of helix was observed to be damaged, exposing 1 electorde wire. On severed part of array, 4 electrode rings and 6 stiffening rings were noted to be damaged. Cuts and other damage in silastic of stimulator body was observed. X-rays of unit showed breaks in electrode wires at tip of helix. Electrical tests: unit passed reflected receiver coil impedance test. Unit passed remote test. Two point probe test could not be performed since electrode array was severed. After exposing electrode feedthroughs, two point probe test was performed at feedthroughs. Full output was obtained for all electrodes. Unit passed test of amplitude growth (at electrode feedthroughs). Conclusion: implant failed due to damage to electrode array at tip of helix. Results of analysis visual inspection found elecrode array severed between helix and stiffening rings. Silastic at tip of helix was damaged, exposing one electrode wire. On severed part of array, four electrode rings and six stiffening rings were noted to be damaged. Cuts and other damage in silastic of stimulator body was observed. X-rays of unit showed breaks in electrode wires at tip of helix. Full electrical output test could not be performed since electorde array was severed. However, after exposing electrode feedthroughs, electrical output test was performed at feedthroughs. Full output was obtained for all electrodes. Unit passed all other electrical tests. Conclusion: implant failed due to damage to electrode array at tip of helix.

 
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Brand NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS
Type of Device22 CHANNEL COCHLEAR IMPLANT FOR ADULTS
Baseline Brand NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Baseline Generic Name22 CHANNEL COCHLEAR IMPLANT
Baseline Catalogue NumberNA
Baseline Model NumberCI22M
Baseline Device FamilyNA
Baseline Device 510(K) Number
Baseline Device PMA NumberP890027
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed10/31/1985
Manufacturer (Section F)
COCHLEAR LTD.
14 mars road
lane cove, nsw
AUSTRALIA 2066
Manufacturer (Section D)
COCHLEAR LTD.
14 mars road
lane cove, nsw
AUSTRALIA 2066
Manufacturer (Section G)
COCHLEAR LTD.
14 mars road
lane cove
AUSTRALIA NSW 2066
Manufacturer Contact
nancy fowler-brehm
61 inverness drive e, ste 200
englewood , CO 80112
(303) 790 -9010
Device Event Key159857
MDR Report Key164231
Event Key154333
Report Number6000034-1998-00024
Device Sequence Number1
Product CodeMCM
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Audiologist
Type of Report Initial,Followup
Report Date 04/22/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL NumberCI22M
OTHER Device ID Number202566
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/02/1998
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Date Manufacturer Received04/09/1998
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/1995
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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