FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 12610042
·
Received October 11, 2021
Report
- Report Number
- 3006630150-2021-05682
- Event Type
- Injury
- Date Received
- October 11, 2021
- Date of Event
- September 21, 2021
- Report Date
- October 11, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7070854.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IPG REVISION (MFR REPORT NUMBER 3006630150-2021-05651), THE PATIENTS ORIGINAL LEADS MIGRATED OUT OF THE EPIDURAL SPACE. THE PHYSICIAN STATED THAT THE LEADS WERE NOT ANCHORED WELL THEREFORE HE DECIDED TO HAVE IT REPLACED. THE PATIENT WAS DONG WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1505973 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7070843 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |