FDA Adverse Event
Injury
Summary report: N
INFINION PRO
MDR report key: 20932581
·
Received December 14, 2024
Report
- Report Number
- 3006630150-2024-08756
- Event Type
- Injury
- Date Received
- December 14, 2024
- Date of Event
- November 19, 2024
- Report Date
- December 14, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218700, MODEL: SC-2318-70, SERIAL: (B)(6) AND BATCH: 5001531. PRODUCT FAMILY: SCS-IPG-PRIME: UPN: M365SC14320, MODEL: SC-1432, SERIAL: (B)(6) AND BATCH: 230134.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS MIDLINE INCISION OPENED UP AND THE SPINAL CORD STIMULATION (SCS) LEAD HAD ERODED. PATIENT UNDERWENT AN SCS EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1995304 | INFINION PRO | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2318-70 | 5001479 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention |