FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 8741166
·
Received June 27, 2019
Report
- Report Number
- 3006630150-2019-03116
- Event Type
- Injury
- Date Received
- June 27, 2019
- Date of Event
- June 19, 2019
- Report Date
- June 27, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789581
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2352-70, SERIAL/LOT: 5127804, DESCRIPTION: LINEAR 3-4 LEAD 70 CM; MODEL: SC-2366-70, SERIAL/LOT: 5071591, 5072403, DESCRIPTION: LINEAR 3-6 LEAD 70 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION, DURING WHICH, HIS LEADS WERE REPOSITIONED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 533628 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-70 | 5098455 | 08714729789581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |