FDA Adverse Event Injury Summary report: N

CARDIAC PACEMAKERS, INC.

MDR report key: 8851 · Received July 29, 1994

Report

Report Number: 8851
Event Type: Injury
Date Received: July 29, 1994
Date of Event: February 3, 1994
Report Date: March 18, 1994
Manufacturer: CARDIAC PACEMAKERS, INC.
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

LEAD REMOVED DUE TO SUSPECTED ALLERGY IN PATIENT. PATIENT HAS DEVELOPED ALLERGIES TO MATERIAL IN LEADS TO POST. THESE LEADS WERE OF AN EXPERIMENTAL MATERIAL PROVIDED BY THE COMPNAY WITHOUT SUCCESS IN IMPLEMENTATION.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CARDIAC PACEMAKERS, INC. Implant	AICD LEAD		CARDIAC PACEMAKERS, INC.	0063

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other