FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2042648
·
Received April 6, 2011
Report
- Report Number
- 3006630150-2011-00472
- Event Type
- Injury
- Date Received
- April 6, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT HAD A POCKET REVISION DUE TO POCKET DISCOMFORT. THE PHYSICIAN CHOSE TO REPLACE THE EXISTING IPG AS THE PATIENT REPORTS DIFFICULTIES CHARGING. THE PATIENT WAS IMPLANTED WITH A NEW IPG AND IS REPORTEDLY DOING WELL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT HAD A POCKET REVISION DUE TO POCKET DISCOMFORT. THE PHYSICIAN CHOSE TO REPLACE THE EXISTING IPG AS THE PATIENT REPORTS DIFFICULTIES CHARGING. THE PATIENT WAS IMPLANTED WITH A NEW IPG AND IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |