FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2030058
·
Received March 25, 2011
Report
- Report Number
- 3006630150-2011-00431
- Event Type
- Injury
- Date Received
- March 25, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 3, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # - SC-1110 SERIAL # - (B)(4) DESCRIPTION - IMPLANTABLE PULSE GENERATOR.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS ALLEGEDLY SUFFERED A BURN FROM THE CHARGER. THE BURN WAS APPROXIMATELY THE SIZE OF THE IPG. THERE IS NO FURTHER INFORMATION AVAILABLE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS ALLEGEDLY SUFFERED A BURN FROM THE CHARGER. THE BURN WAS APPROXIMATELY THE SIZE OF THE IPG. THERE IS NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-5312 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |