PRECISION MONTAGE MRI
Report
- Report Number
- 3006630150-2018-00435
- Event Type
- Injury
- Date Received
- February 2, 2018
- Date of Event
- December 28, 2017
- Report Date
- April 25, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
SC-1200 (B)(4) DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. IT WAS NOTED THAT THE PATIENT FELT IT WAS HOT POCKET, JABBING AND GOT SHOCKED FROM IT. THE PATIENT WILL UNDERGO A POCKET REVISION AND IPG REPLACEMENT PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. IT WAS NOTED THAT THE PATIENT FELT IT WAS HOT POCKET, JABBING AND GOT SHOCKED FROM IT. THE PATIENT WILL UNDERGO A POCKET REVISION AND IPG REPLACEMENT PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. IT WAS NOTED THAT THE PATIENT FELT IT WAS HOT POCKET, JABBING AND GOT SHOCKED FROM IT. THE PATIENT WILL UNDERGO A POCKET REVISION AND IPG REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78725 | PRECISION MONTAGE MRI | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | NA | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |