FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3954172
·
Received July 23, 2014
Report
- Report Number
- 3006630150-2014-01672
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 1, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429989 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |