PRECISION®
Report
- Report Number
- 3006630150-2014-02188
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- August 13, 2014
- Report Date
- September 4, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHEREIN THE IPG WAS REPLACED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME.
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG COULD NOT HOLD A CHARGE. THE STIMULATOR HAD NOT WORKED THE SAME SINCE A LIGHTNING STRUCK CLOSE TO THE PATIENT¿S HOUSE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG COULD NOT HOLD A CHARGE. THE STIMULATOR HAD NOT WORKED THE SAME SINCE A LIGHTNING STRUCK CLOSE TO THE PATIENT¿S HOUSE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG COULD NOT HOLD A CHARGE. THE STIMULATOR HAD NOT WORKED THE SAME SINCE A LIGHTNING STRUCK CLOSE TO THE PATIENT¿S HOUSE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600708 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |