LINEAR ST
Report
- Report Number
- 3006630150-2021-04863
- Event Type
- Injury
- Date Received
- August 30, 2021
- Date of Event
- August 5, 2021
- Report Date
- September 22, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
CORRECTION TO INITIAL MDR IN FIELD D6A. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT- UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: (B)(6).
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF PARESTHESIA OF PAIN AREAS. HIGH IMPEDANCES WERE NOTED ON BOTH LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN IMPLANTED ONE NEW LEAD, AND UPGRADED THE IMPLANTABLE PULSE GENERATOR (IPG). THE TWO LEADS THAT DISPLAYED HIGH IMPEDANCES REMAIN IMPLANTED. THE EXPLANTED IPG WAS DISCARDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7071970.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF PARESTHESIA OF PAIN AREAS. HIGH IMPEDANCES WERE NOTED ON BOTH LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN IMPLANTED ONE NEW LEAD, AND UPGRADED THE IMPLANTABLE PULSE GENERATOR (IPG). THE TWO LEADS THAT DISPLAYED HIGH IMPEDANCES REMAIN IMPLANTED. THE EXPLANTED IPG WAS DISCARDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1279966 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 19518064 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |