FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 2939434
·
Received February 1, 2013
Report
- Report Number
- 3006630150-2013-00167
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Report Date
- January 14, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2012, ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM MODEL #: SC-4316 LOT #: 14304850 DESCRIPTION: CLIK ANCHOR.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO AN IPG REPLACEMENT PROCEDURE. THE BSN SALES REPRESENTATIVE WAS ABLE TO GET THE PATIENT'S IPG TO BE FULLY CHARGED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT SCS WAS NOT WORKING. IPG REPLACEMENT HAS BEEN RECOMMENDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT SCS WAS NOT WORKING. IPG REPLACEMENT HAS BEEN RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45161 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |