FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 11968890
·
Received June 9, 2021
Report
- Report Number
- 3006630150-2021-02788
- Event Type
- Injury
- Date Received
- June 9, 2021
- Date of Event
- May 18, 2021
- Report Date
- June 9, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789581
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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: M365SC2352700, MODEL: SC-2352-70, SERIAL:(B)(4), BATCH: 7070853.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED AS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864142 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-70 | 5007679 | 08714729789581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |