FDA Adverse Event Malfunction Summary report: N

ATTAIN OTW

MDR report key: 1072989 · Received July 10, 2008

Report

Report Number
2649622-2008-03719
Event Type
Malfunction
Date Received
July 10, 2008
Date of Event
January 8, 2008
Manufacturer
MEDTRONIC PUERTO RICO, INC.
Product Code
LWP
Removal / Correction Number
NI
Report Source
Manufacturer report
Reporter Location
IA
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. 4193 NA

Patients

Seq Age Sex Outcome Treatment
1 74 YR Other 5072 IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB