FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 4760067
·
Received May 8, 2015
Report
- Report Number
- 3006630150-2015-01193
- Event Type
- Malfunction
- Date Received
- May 8, 2015
- Date of Event
- February 16, 2015
- Report Date
- April 28, 2015
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG WAS REPLACED PER PHYSICIAN¿S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. 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 WAS EXPERIENCING FREQUENT IPG CHARGING. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING FREQUENT IPG CHARGING. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304744 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |