FDA Adverse Event Injury Summary report: N

SPRINT QUATTRO SECURE

MDR report key: 1050036 · Received May 8, 2008

Report

Report Number
2649622-2008-02598
Event Type
Injury
Date Received
May 8, 2008
Date of Event
August 2, 2007
Manufacturer
MEDTRONIC PUERTO RICO, INC.
Product Code
LWS
Removal / Correction Number
NI
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX
Reporter Occupation
INVALID DATA

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 NA

Patients

Seq Age Sex Outcome Treatment
1 58 YR Required Intervention 7289 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD