PRECISION®
Report
- Report Number
- 3006630150-2014-01751
- Event Type
- Injury
- Date Received
- August 1, 2014
- Date of Event
- May 27, 2014
- Report Date
- July 10, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO IPG REPLACEMENT DONE. THE BATTERY WAS JUST MOVED TO ANOTHER LOCATION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE BATTERY SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPLACED PER PREFERENCE AND WILL BE MOVED TO A COMFORTABLE LOCATION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE BATTERY SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPLACED PER PREFERENCE AND WILL BE MOVED TO A COMFORTABLE LOCATION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE BATTERY SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPLACED PER PREFERENCE AND WILL BE MOVED TO A COMFORTABLE LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450595 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |