FDA Adverse Event
Malfunction
Summary report: N
IDENTITY XL DR
MDR report key: 3925745
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15230
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- April 16, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z0298
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT WAS PRESENTED TO THE OPERATING ROOM FOR A ROUTINE PULSE GENERATOR CHANGEOUT PROCEDURE. THE PULSE GENERATOR EXHIBITED BACKUP OPERATION. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404348 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |