FDA Adverse Event
Injury
Summary report: N
RENEW RECEIVER
MDR report key: 4212886
·
Received October 24, 2014
Report
- Report Number
- 1627487-2014-12710
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 29, 2014
- Manufacturer
- ST. JUDE MED - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2014-12711. IT WAS REPORTED THE PATIENT'S SYSTEM IS NOT WORKING CORRECTLY. THE PATIENT IS PENDING A SURGICAL CONSULT WITH THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678879 | RENEW RECEIVER | SCS RECEIVER | GZB | ST. JUDE MED - NEUROMODULATION | 3416 | 156221B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |