FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 2772016
·
Received October 2, 2012
Report
- Report Number
- 1627487-2012-02404
- Event Type
- Injury
- Date Received
- October 2, 2012
- Date of Event
- September 5, 2012
- Report Date
- September 5, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02403. IT WAS REPORTED THE PATIENT SUDDENLY LOST STIMULATION. SHE REPORTED WHEN SHE TRIED TO RESTART HER SYSTEM, SHE FELT A JOLT IN HER RIBS AND HER STIMULATION SHUT BACK DOWN. SHE STATED SHE HAD RECENTLY RECHARGED HER IPG WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AS ATTEMPTS TO FOLLOW UP WITH THE PATIENT HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3463282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |