FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 12188046
·
Received July 19, 2021
Report
- Report Number
- 3006630150-2021-03863
- Event Type
- Injury
- Date Received
- July 19, 2021
- Date of Event
- March 27, 2021
- Report Date
- September 15, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR LEAD EXPLANT WAS DUE TO LEAD MIGRATION.
Additional Manufacturer Narrative · 1
DATE OF EVENT: THE EXACT DATE OF THE EVENT IS UNKNOWN, EVENT OCCURRED 3 MONTHS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7080903.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1087234 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7077401 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |