FDA Adverse Event
Injury
Summary report: N
LINEAR 3-6
MDR report key: 8966269
·
Received September 5, 2019
Report
- Report Number
- 3006630150-2019-04840
- Event Type
- Injury
- Date Received
- September 5, 2019
- Date of Event
- August 18, 2019
- Report Date
- September 5, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789574
- 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: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 5070918. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5105534. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5141768.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE THERAPY DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE SUCCESSFULLY REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758537 | LINEAR 3-6 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2366-50 | 5058667 | 08714729789574 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |