FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 7272121
·
Received February 14, 2018
Report
- Report Number
- 3006630150-2018-00474
- Event Type
- Injury
- Date Received
- February 14, 2018
- Date of Event
- January 29, 2018
- Report Date
- March 7, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2108-50 SERIAL #: (B)(4) DESCRIPTION: SCS LEAD KIT, PHASE 2 STERILE PACKAGE.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO NO LONGER NEEDING THE DEVICE AND HAD STOPPED CHARGING IT. THE PHYSICIAN DID NOT SUSPECT DEVICE MALFUNCTION. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115167 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |