FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3111395
·
Received May 2, 2013
Report
- Report Number
- 1627487-2013-02602
- Event Type
- Injury
- Date Received
- May 2, 2013
- Date of Event
- August 24, 2011
- Report Date
- August 24, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-02603. IT WAS REPORTED THE PT FELT INEFFECTIVE STIMULATION FROM HER SCS SYSTEM. THE PHYSICIAN CONSEQUENTLY EXPLANTED AND REPLACED THE SYSTEM ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193458 | PENTA | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3173104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |