FDA Adverse Event
Death
Summary report: N
VICTORY XL SR
MDR report key: 2970459
·
Received February 20, 2013
Report
- Report Number
- 2017865-2013-01322
- Event Type
- Death
- Date Received
- February 20, 2013
- Date of Event
- January 15, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWP
- PMA / PMN Number
- P880086
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74711 | VICTORY XL SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5610 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death | (B)(4) |