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Adverse Event Report

CARDIAC PACEMAKERS, INC ENDOTAK RELIANCE IMPLANTABLE LEAD   back to search results
Model Number 0157
Device Problem Normal
Event Date 02/20/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Event description guidant received information that the patient with this implantable lead exhibited symptoms of pericardial effusion. The lead was explanted and the patient was stabilized.

 
Manufacturer Narrative

Event conclusion this lead was explanted and replaced with another guidant product. No additional information is available at this time. This event will be reopened if additional information becomes available.

 
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Brand NameENDOTAK RELIANCE
Type of DeviceIMPLANTABLE LEAD
Baseline Brand NameENDOTAK RELIANCE
Baseline Generic NameIMPLANTABLE LEAD
Baseline Catalogue NumberNA
Baseline Model Number0157
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIAC PACEMAKERS, INC
guidant puerto rico b.v.
#12, rd. #698
dorado PR 00646 UNK
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC
guidant puerto rico b.v.
#12, rd. #698
dorado PR 00646 UNK
Manufacturer (Section G)
CARDIAC PACEMAKERS, INC.
4100 hamline ave., north
st. paul MN 55112 5798
Device Event Key533433
MDR Report Key544025
Event Key516697
Report Number2124215-2004-08386
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 02/20/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device EXPIRATION Date12/28/2004
Device MODEL Number0157
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/01/2004
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age25 mo
Event Location Hospital
Date Report TO Manufacturer02/20/2003
Date Manufacturer Received02/20/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/28/2000
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/10/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1 THE DEVICE 4469/326297 WAS IMPLANTED 20-FEB-2003 02/20/2003
2 THE DEVICE 0148/126338 WAS IMPLANTED 26-FEB-2003 02/26/2003
3 THE DEVICE 1861/246822 WAS IMPLANTED 26-FEB-2003 02/26/2003
4 THE DEVICE 4479/310474 WAS IMPLANTED 26-FEB-2003 02/26/2003

Database last updated on February 28, 2009

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