FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3871606
·
Received June 13, 2014
Report
- Report Number
- 3007566237-2014-01633
- Event Type
- Injury
- Date Received
- June 13, 2014
- Report Date
- May 21, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED FOR MRI. THE PATIENT HAD INTERSTIM SYSTEM REMOVED LAST WEEK BUT PART OF LEAD BROKE OFF AND REMAINS IN THE PATIENT. HCP (HEALTHCARE PROVIDER) CALLED MANUFACTURER AT THAT TIME AND WAS TOLD THAT AS LONG AS LEAD LENGTH LEFT IN THE PATIENT WAS LESS THAN 6 CENTIMETER IT WAS OKAY TO HAVE FULL BODY MRI. THE PATIENT NEEDS PELVIC MRI PER HCP. IT WAS REVIEWED THAT THE MANUFACTURER COMPANY DIDN'T HAVE ANY DOCUMENTATION ABOUT LEAD LENGTHS THAT CAN BE LEFT IN THAT WOULDN'T CREATE RISK FOR THE PATIENT DURING MRI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350541 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |