FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 12724337
·
Received October 29, 2021
Report
- Report Number
- 3006630150-2021-06092
- Event Type
- Injury
- Date Received
- October 29, 2021
- Date of Event
- October 7, 2021
- Report Date
- October 29, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7072967.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOST OF STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE HOWEVER, THE PROCEDURE WAS ABORTED DUE TO THE PATIENT HAD TOO MUCH SCAR TISSUE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1617167 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 7073005 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |