FDA Adverse Event
Injury
Summary report: N
PROTEGE IPG, 16-CHANNEL RECHARGEABLE
MDR report key: 9245281
·
Received October 28, 2019
Report
- Report Number
- 3006705815-2019-04183
- Event Type
- Injury
- Date Received
- October 28, 2019
- Date of Event
- October 15, 2019
- Report Date
- October 30, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05414734405690
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Additional Manufacturer Narrative · 1
DEVICE PRODUCT CODE (FDA PRODUCT CODE CLASSIFICATION): THE DEVICE PRODUCT CODE WAS CORRECTED TO LGW FROM DLG
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1038427 | PROTEGE IPG, 16-CHANNEL RECHARGEABLE | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3789 | 4682905 | 05414734405690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |