FDA Adverse Event
Malfunction
Summary report: N
IDENTITY XL DR
MDR report key: 4855085
·
Received June 18, 2015
Report
- Report Number
- 2017865-2015-07897
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Date of Event
- April 30, 2015
- Report Date
- April 30, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- Removal / Correction Number
- Z0298
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH PALPITATIONS. THE PULSE GENERATOR EXHIBITED BACK-UP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REMOVED ON (B)(6) 2015 FOR NORMAL ERI. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397421 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 5376 | 0002283957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR |