FDA Adverse Event Injury Summary report: N

ATTAIN OTW

MDR report key: 1072422 · Received July 10, 2008

Report

Report Number
2649622-2008-03371
Event Type
Injury
Date Received
July 10, 2008
Date of Event
August 21, 2007
Manufacturer
MEDTRONIC PUERTO RICO, INC.
Product Code
LWP
Removal / Correction Number
NI
Report Source
Manufacturer report
Reporter Location
WA
Reporter Occupation
INVALID DATA

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ATTAIN OTW IMPLANTABLE PACING LEAD LWP MEDTRONIC PUERTO RICO, INC. 4194 NA

Patients

Seq Age Sex Outcome Treatment
1 84 YR Required Intervention 4574 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB