FDA Adverse Event Injury Summary report: N

LASERPOR 030-236

MDR report key: 77025 · Received March 15, 1997

Report

Report Number
1316542-1997-00522
Event Type
Injury
Date Received
March 15, 1997
Date of Event
August 23, 1996
Report Date
March 14, 1997
Manufacturer
TELECTRONICS PACING SYSTEMS
Product Code
DTB
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE LEAD WAS CUT & CAPPED DUE TO A REPORT OF LEAD LOSS OF SENSING AND CAPTURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LASERPOR 030-236 Implant CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE DTB TELECTRONICS PACING SYSTEMS 030-236 NA

Patients

Seq Age Sex Outcome Treatment
1 74 YR Required Intervention