FDA Adverse Event
Injury
Summary report: N
PRECISION? MONTAGE? MRI
MDR report key: 21940872
·
Received May 1, 2025
Report
- Report Number
- 3006630150-2025-02961
- Event Type
- Injury
- Date Received
- May 1, 2025
- Date of Event
- April 7, 2021
- Report Date
- May 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SEVERAL YEARS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. D6B: EXPLANT DATE: SEVERAL YEARS AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(6), BATCH: 7070159/7070607, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. ALL COMPONENTS WERE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICES WERE DISCARDED PER HOSPITAL POLICY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. ALL COMPONENTS WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189008 | PRECISION? MONTAGE? MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1200 | 370073 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |