FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3644343
·
Received February 25, 2014
Report
- Report Number
- 3004209178-2014-03508
- Event Type
- Malfunction
- Date Received
- February 25, 2014
- Date of Event
- January 31, 2014
- Report Date
- February 3, 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
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 3093-28, LOT# V850461, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS AT THE CHIROPRACTOR FOUR DAYS PRIOR AND DIATHERMY WAS DONE. THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION AND THE USE OF DIATHERMY WAS DISCONTINUED. IT WAS NOTED THE PATIENT HAD NOT HAD ANY CHANGES TO THERAPY SINCE THE APPOINTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115812 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Male |