FDA Adverse Event Injury Summary report: N

ATTAIN OTW

MDR report key: 1072769 · Received July 10, 2008

Report

Report Number
2649622-2008-03548
Event Type
Injury
Date Received
July 10, 2008
Date of Event
November 8, 2007
Manufacturer
MEDTRONIC PUERTO RICO, INC.
Product Code
LWP
Removal / Correction Number
NI
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA
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 60 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR