FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2990229
·
Received March 5, 2013
Report
- Report Number
- 3004209178-2013-03335
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Report Date
- February 12, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3093-28, LOT# V800436, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "LOSS OF THERAPEUTIC EFFECT" SINCE "ABOUT THREE MONTHS" PRIOR TO REPORT. WITH THE STIMULATION ON A MAXIMUM SETTING, THE PATIENT REPORTED THAT THEY "COULDN'T FEEL STIMULATION." IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD BEEN FALLING "DUE TO PARKINSON'S DISEASE" AND THAT THE PATIENT WAS "IN REHAB FROM A FALL DOWN THE STAIRS ON (B)(6) 2013. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93783 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |