FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3072741
·
Received April 23, 2013
Report
- Report Number
- 3006630150-2013-00768
- Event Type
- Injury
- Date Received
- April 23, 2013
- Report Date
- March 25, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S IPG ROTATED IN THE POCKET AND THERE WAS NO BREAKAGE IN THE SKIN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING POCKET PAIN AND DIFFICULTY CHARGING THE IPG. THE IPG HEADER WAS VISIBLY POKING OUT ON THE PATIENT'S BACK BUT IT WAS UNCLEAR IF THERE WAS AN ACTUAL BREAK ON THE PATIENT'S SKIN. THE PATIENT WILL UNDERGO A POCKET REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING POCKET PAIN AND DIFFICULTY CHARGING THE IPG. THE IPG HEADER WAS VISIBLY POKING OUT ON THE PATIENT¿S BACK BUT IT WAS UNCLEAR IF THERE WAS AN ACTUAL BREAK ON THE PATIENT¿S SKIN. THE PATIENT WILL UNDERGO A POCKET REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175314 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |