FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3677218
·
Received March 13, 2014
Report
- Report Number
- 3004209178-2014-04399
- Event Type
- Injury
- Date Received
- March 13, 2014
- Report Date
- February 19, 2014
- 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
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V013823, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. AN EXPLANT WAS PLANNED. THERE WAS A REPROGRAMMING TRIED AND IMPEDANCE TESTING WAS DONE ALONG WITH X-RAYS BEING TAKEN. THE PATIENT ALSO HAD PAIN AT THE IMPLANT SITE AND DEVICE POCKET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 151020 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |