FDA Adverse Event Injury Summary report: N

POSSIS SUTURELESS MYOCARDIAL LEAD

MDR report key: 25334 · Received January 18, 1995

Report

Report Number: 2124215-1994-00107
Event Type: Injury
Date Received: January 18, 1995
Date of Event: December 9, 1994
Report Date: December 15, 1994
Manufacturer: PSSIS MEDICAL, INC.
Product Code: DTD
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: MN, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

DISTRIBUTOR RECEIVED INFORMATION THAT A PT WITH AN AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) RECEIVED MULTIPLE OCKS. THE DR. PERFORMED AN INVASIVE EPROCEDURE TO EVALUATE THE SYSTEM AND TO REPLACE THE AICD FOR ELECTIVE REPLACEMENT INDICATORS (ERI). DURING THE PROCEDURE THE PHYSCIAN WAS NOT ABLE TO IDENTIFY AN OBVIOUS PROBLEM WITH THE LEADS. THE PHYSICIAN ELECTED TO REMOVE THIS LEAD AND MODEL SERIAL NUMBER FROM SERVICE AND IMPLANT A BIPOLAR ENDOCARDIAL TINED LEAD. IMPLANT DATE 10/16/91. REMOVED FROM 12/9/94. TOTAL IMPLANT TIME 37 MONTHS.0DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POSSIS SUTURELESS MYOCARDIAL LEAD Implant	LEAD	DTD	PSSIS MEDICAL, INC.	4320

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention