FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 3148071
·
Received June 5, 2013
Report
- Report Number
- 3004209178-2013-08679
- Event Type
- Injury
- Date Received
- June 5, 2013
- Report Date
- May 16, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT # V062663, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD RECENTLY BEEN IN THE HOSPITAL FOR SEVERE LOW BACK PAIN AND WOULD NEED AN MRI. THE PATIENT WAS REQUESTING COMPATIBILITY GUIDELINES FOR AN MRI. IT WAS INDICATED THAT THE PATIENT WAS GOING TO CONTACT HER PHYSICIAN TO HAVE THE DEVICE REMOVED BECAUSE SHE HAD TO HAVE THE MRI. APPROXIMATELY 3 WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS HAVING THE IMPLANTABLE NEUROSTIMULATOR TAKEN OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249062 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |