FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2801547
·
Received October 23, 2012
Report
- Report Number
- 3006630150-2012-01924
- Event Type
- Injury
- Date Received
- October 23, 2012
- Date of Event
- September 28, 2012
- Report Date
- September 28, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE DUE TO THE IPG BEING TILTED IN THE POCKET. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS TILTED IN THE POCKET AND WAS CAUSING CHARGING DIFFICULTIES. THE PATIENT WILL UNDERGO A POCKET REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS TILTED IN THE POCKET AND WAS CAUSING CHARGING DIFFICULTIES. THE PATIENT WILL UNDERGO A POCKET REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS TILTED IN THE POCKET AND WAS CAUSING CHARGING DIFFICULTIES. THE PATIENT WILL UNDERGO A POCKET REVISION.
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 | 49 YR | Required Intervention |