FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 4183329
·
Received October 18, 2014
Report
- Report Number
- 3006630150-2014-02372
- Event Type
- Malfunction
- Date Received
- October 18, 2014
- Date of Event
- August 25, 2014
- Report Date
- August 25, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WOULD NOT HOLD A CHARGE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPLACED. THE PHYSICIAN DID NOT THINK THAT THERE WAS ANYTHING WRONG WITH THE OLD BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663758 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |