FDA Adverse Event
Injury
Summary report: N
PRECISION? MONTAGE? MRI
MDR report key: 22399160
·
Received July 3, 2025
Report
- Report Number
- 3006630150-2025-05125
- Event Type
- Injury
- Date Received
- July 3, 2025
- Date of Event
- June 9, 2025
- Report Date
- July 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500/M365SC2352700, MODEL: SC-2352-50/SC-2352-70, SERIAL: (B)(6), BATCH: 7071725/5167871, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) POPPED OUT OF HER SPINE 3 TIMES. THE PATIENT UNDERWENT A SCS EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1803309 | PRECISION? MONTAGE? MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1200 | 370973 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |