PRECISION®
Report
- Report Number
- 3006630150-2013-01533
- Event Type
- Injury
- Date Received
- July 23, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 26, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
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.
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WOULD NOT CHARGE AND WOULD NOT COMMUNICATE WITH THE REMOTE CONTROL. THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AT THE POCKET SITE. X-RAY CONFIRMED THAT THE IPG FLIPPED. THE PATIENT WILL UNDERGO REVISION PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WOULD NOT CHARGE AND WOULD NOT COMMUNICATE WITH THE REMOTE CONTROL. THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AT THE POCKET SITE. X-RAY CONFIRMED THAT THE IPG FLIPPED. THE PATIENT WILL UNDERGO REVISION PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WOULD NOT CHARGE AND WOULD NOT COMMUNICATE WITH THE REMOTE CONTROL. THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AT THE POCKET SITE. X-RAY CONFIRMED THAT THE IPG FLIPPED. THE PATIENT WILL UNDERGO REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343716 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |