FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3081664
·
Received April 29, 2013
Report
- Report Number
- 3004209178-2013-06980
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 9, 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
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V266475. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE ANY CONCERNS WITH THEIR DEVICE THERAPY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH HER NEW DEVICE AND WAS SENT HOME ON PROGRAM 2 AT 5.09 V. AT THIS SETTING, THE DEVICE WAS SHOCKING AND THROBBING AND VERY PAINFUL FOR THE PATIENT. THE PATIENT TURNED IT TO A LOWER SETTING AND THEN HAD A RETURN OF SYMPTOMS. THE PATIENT WAS CURRENTLY ON PROGRAM 1 AT 2.0 V WHERE THE PATIENT FELT IT COMFORTABLY AND IT WAS CONTROLLING HER SYMPTOMS VERY WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185176 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |