FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 4183348
·
Received October 18, 2014
Report
- Report Number
- 3006630150-2014-02381
- Event Type
- Malfunction
- Date Received
- October 18, 2014
- Date of Event
- September 24, 2014
- Report Date
- September 24, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CHARGING ISSUES WITH THE IPG AFTER SHE WAS SCANNED WITH THE WAND IN THE AIRPORT. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPLACED AND UPGRADED. IT WAS THE PHYSICIAN¿S DECISION TO UPGRADE. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663817 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |