FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3123067
·
Received May 21, 2013
Report
- Report Number
- 3006630150-2013-01003
- Event Type
- Injury
- Date Received
- May 21, 2013
- Date of Event
- April 24, 2013
- Report Date
- April 25, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: LINEAR ST LEAD, 50CM DESCRIPTION: (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING LEG PAIN AND WEAKNESS AFTER THE IMPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THE WEAKNESS WAS DUE TO THE LEAD BEING POSITIONED ANTERIORLY. THE PATIENT UNDERWENT A LEAD REVISION AND WAS DOING WELL POST-OPERATIVELY. THE PATIENT¿S LEG WEAKNESS HAS BEEN RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224756 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |