PRECISION MONTAGE
Report
- Report Number
- 3006630150-2016-03274
- Event Type
- Injury
- Date Received
- November 11, 2016
- Date of Event
- October 25, 2016
- Report Date
- October 25, 2016
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2408-74 SERIAL: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 74 CM.
MODEL: SC-2408-74 SERIAL: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 74 CM LEADS SC-2408-74 SN (B)(4), PASSED ALL CIS TESTING AND EXHIBIT NORMAL DEVICE CHARACTERISTICS.
A REPORT WAS RECEIVED THAT THE SURGICAL IMPLANT PROCEDURE TOOK ABOUT TWO HOURS TO COMPLETE. THE PHYSICIAN HAD DIFFICULTY IMPLANTING AND POSITIONING THE LEADS DUE TO THE SHARPNESS OF THE PATIENT'S SPINAL CORD AND CURVE OF THE SPINE. THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY IMPLANT THE LEADS, THEREFORE, STIFFER LEADS FROM ANOTHER COMPANY WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
A REPORT WAS RECEIVED THAT THE SURGICAL IMPLANT PROCEDURE TOOK ABOUT TWO HOURS TO COMPLETE. THE PHYSICIAN HAD DIFFICULTY IMPLANTING AND POSITIONING THE LEADS DUE TO THE SHARPNESS OF THE PATIENT'S SPINAL CORD AND CURVE OF THE SPINE. THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY IMPLANT THE LEADS, THEREFORE, STIFFER LEADS FROM ANOTHER COMPANY WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746721 | PRECISION MONTAGE | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-74 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |