FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3962208
·
Received July 28, 2014
Report
- Report Number
- 3006630150-2014-01702
- Event Type
- Injury
- Date Received
- July 28, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 7, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2138-50, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS 50CM III LEAD; MODEL #: SC-2138-70, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS 70CM III LEAD.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INEFFECTIVE THERAPY AND IT WAS ALSO REPORTED THAT THE DEVICES WERE WORKING PROPERLY. 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 UNKNOWN REASON.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE FOR UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439242 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |