FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2592684
·
Received May 30, 2012
Report
- Report Number
- 3006630150-2012-00965
- Event Type
- Injury
- Date Received
- May 30, 2012
- Date of Event
- March 1, 2012
- Report Date
- March 1, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE. THE PHYSICIAN OPENED UP THE INCISION WHERE THE EXTENSIONS WERE LOCATED AND BURIED THE EXTENSIONS DEEPER AS ONE OF THE EXTENSIONS WAS BULGING OUT AND POKING THE PATIENT. THE IPG POCKET SITE WAS NOT REVISED AND THE PATIENT IS REPORTEDLY DOING WELL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-3138-35, SERIAL #S (B)(4), DESCRIPTION: SCS PHIII EXTENSION 35CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDER GO A REVISION DUE TO THE IPG MOVING WITHIN THE POCKET SITE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDER GO A REVISION DUE TO THE IPG MOVING WITHIN THE POCKET SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |