FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 3834044
·
Received May 27, 2014
Report
- Report Number
- 3006630150-2014-01207
- Event Type
- Malfunction
- Date Received
- May 27, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 24, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE PER PHYSICIAN'S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG 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 NOT ABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT ABLE TO CHARGE THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310840 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |