FDA Adverse Event
Injury
Summary report: N
PRECISION? MONTAGE? MRI
MDR report key: 23136873
·
Received September 24, 2025
Report
- Report Number
- 3006630150-2025-07984
- Event Type
- Injury
- Date Received
- September 24, 2025
- Date of Event
- September 5, 2025
- Report Date
- September 24, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7072151, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING SUFFICIENT RELIEF AND PATIENT WAS FEELING ZAPPING SENSATIONS WHEN STIMULATION WAS ON. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT RECOVERED WELL. NO PRODUCT WILL BE RETURNED, PER HOSPITAL POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2393898 | PRECISION? MONTAGE? MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1200 | 373074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |