PRECISION SPECTRA®
Report
- Report Number
- 3006630150-2014-01997
- Event Type
- Injury
- Date Received
- September 4, 2014
- Date of Event
- August 7, 2014
- Report Date
- August 7, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT UNDERGO THE CT GUIDED ASPIRATION. IT WAS ALSO REPORTED THAT THERE WAS NO BLOOD CLOT, THE BATTERY WAS JUST ON ITS EDGE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE AND TROUBLE CHARGING THE IPG. THE PHYSICIAN FELT THAT IT WAS LIKELY A BLOOD CLOT IN THE IMPLANT SITE AND IPG WAS TOO DEEP THAT CAUSED DIFFICULTY CHARGING. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE BLOOD CLOT. THE PATIENT WAS SENT FOR A CT GUIDED ASPIRATION OF THE POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE AND TROUBLE CHARGING THE IPG. THE PHYSICIAN FELT THAT IT WAS LIKELY A BLOOD CLOT IN THE IMPLANT SITE AND IPG WAS TOO DEEP THAT CAUSED DIFFICULTY CHARGING. THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE BLOOD CLOT. THE PATIENT WAS SENT FOR A CT GUIDED ASPIRATION OF THE POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541543 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |