FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

CARDIAC PACEMAKERS BIPOLAR ENDOCARDIAL LEAD BIPOLAR LEAD   back to search results
Model Number 4261
Event Date 05/26/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description cpi received information that this bipolar endocardial lead (4261) was cut during a replacement procedure of an implantable pulse generator (ipg). The physician elected to remove the (4261), and replace it with a (4285).

 
Manufacturer Narrative

Event conclusion the lead has been capped, and will not be returned for analysis.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameBIPOLAR ENDOCARDIAL LEAD
Type of DeviceBIPOLAR LEAD
Baseline Brand NameBIPOLAR POROUS
Baseline Generic NameLEAD
Baseline Catalogue NumberNA
Baseline Model Number4261
Baseline Device FamilyPTIP
Baseline Device 510(K) NumberK893957
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed08/10/1983
Manufacturer (Section F)
CARDIAC PACEMAKERS
guidant corporation
4100 hamline avenue north
saint paul MN 55112 UNK
Manufacturer (Section D)
CARDIAC PACEMAKERS
guidant corporation
4100 hamline avenue north
saint paul MN 55112 UNK
Manufacturer (Section G)
CARDIAC PACEMAKERS, INC.
4100 hamline ave., north
st. paul MN 55112 5798
Manufacturer Contact
jason holeman
4100 hamline ave n
st. paul , MN 55112
(651) 582 -5864
Device Event Key107279
MDR Report Key109145
Event Key102653
Report Number2124215-1997-02026
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 05/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL Number4261
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Report TO Manufacturer05/26/1997
Date Manufacturer Received05/26/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/08/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1 THE DEVICE 0940/750237 WAS IMPLANTED 22-JUL-1991 07/22/1991
2 THE DEVICE 4269/011770 WAS IMPLANTED 22-JUL-1991 07/22/1991
3 THE DEVICE 4285/224381 WAS IMPLANTED 26-MAY-1997 05/26/1997
4 THE DEVICE 0950/404348 WAS IMPLANTED 26-MAY-1997 05/26/1997

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH