FDA Adverse Event
Injury
Summary report: N
AVISTA MRI
MDR report key: 9245868
·
Received October 28, 2019
Report
- Report Number
- 3006630150-2019-06025
- Event Type
- Injury
- Date Received
- October 28, 2019
- Date of Event
- August 13, 2019
- Report Date
- February 21, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904823
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
LEAD MODEL SC-2408-74, SERIAL NUMBER (B)(4). THE RETURNED LEAD WAS ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 0
A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INEFFECTIVE THERAPY. AN XRAY CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS STABLE POST OPERATIVELY
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT DEVICE: MODEL NUMBER SC-2408-74, AVISTA MRI PERC LEAD KIT 74 CM, SERIAL NUMBER (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS RECEIVING INEFFECTIVE THERAPY. AN XRAY CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS STABLE POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1040962 | AVISTA MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-74 | 21717025 | 08714729904823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |