FDA Adverse Event
Injury
Summary report: N
PRECISION ?
MDR report key: 23347015
·
Received October 21, 2025
Report
- Report Number
- 3006630150-2025-09332
- Event Type
- Injury
- Date Received
- October 21, 2025
- Date of Event
- September 29, 2025
- Report Date
- December 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729121688
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.
Additional Manufacturer Narrative · 0
BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SINCE IMPLANT PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC SKIN REACTION TO THE ADHESIVE RELATED DUE TO EXISTING ALLERGY. PATIENT WAS PRESCRIBED CIPRO 500MG.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC SKIN REACTION TO THE ADHESIVE RELATED DUE TO EXISTING ALLERGY. PATIENT WAS PRESCRIBED CIPRO 500MG. ADDITIONAL INFORMATION STATED THAT THE AREAS HAVE IMPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2284654 | PRECISION ? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-6350 | 08714729121688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Other |