FDA Adverse Event Injury Summary report: N

POSSIS SUTURELESS MYOCARDIAL LEAD

MDR report key: 28848 · Received November 21, 1995

Report

Report Number: 2124215-1995-00104
Event Type: Injury
Date Received: November 21, 1995
Date of Event: November 8, 1995
Report Date: November 20, 1995
Manufacturer: POSSIS MEDICAL, INC.
Product Code: LWS
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CT, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

CO RECEIVED INFO THAT THIS PT RECEIVED INAPPROPRIATE SHOCKS FROM HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INVASIVE PROCEDURE WAS PERFORMED TO EVALUATE THE SYSTEM. THE PHYSICIAN REMOVED BOTH OF THE PT'S MODEL 4320 RATE SENSING LEADS FROM SVC BECAUSE OF A FRACTURE. THE SERIAL NUMBERS OF THE LEADS ARE 012951 AND 012955. BOTH LEADS WERE CAPPED AND REMAIN IMPLANTED. IMPLANTED 1/15/92. REMOVED FROM SVC 11/8/95. TOTAL IMPLANT TIME 45 MONTHS.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: INVALID DATA. 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	LEAD	LWS	POSSIS MEDICAL, INC.	4320	N

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention