FDA Adverse Event Summary report: N

HIGHRATE PACEMAKER BATTERY

MDR report key: 65772 · Received January 31, 1997

Report

Report Number
MW4001758
Date Received
January 31, 1997
Report Date
November 25, 1996
Manufacturer
MEDTRONIC, INC.
Product Code
DSZ
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

PROBLEMS WITH POTENTIAL METAL ARTICLE CONTAMINATION AND WITH THE PLASTIC "HEADSPACE INSULATOR."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HIGHRATE PACEMAKER BATTERY Implant PACEMAKER BATTERY DSZ MEDTRONIC, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 *