INTERSTIM
Report
- Report Number
- 3004209178-2013-06983
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 10, 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
- WA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-28, LOT# J0437154V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH DEVICE OR THERAPY BUT HAVE NOT SOUGHT FURTHER HELP. THE PATIENT REPORTEDLY ¿TRIED TOO MANY TIMES WITHOUT RESOLUTION,¿ AND HAD ¿GIVEN UP¿ AND WANTED IT REMOVED TO RECEIVE AN MRI FOR ANOTHER PROBLEM.
IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE DEVICE HAD NOT WORKED FOR 2-3 YEARS. IT WAS NOTED THE DEVICE DID NOT "STAY STEADY AND WAS NOT CONSISTENT." THE PATIENT HAD THE DEVICE OFF AS THEY HAVE NOT USED IT AND IT HAD NOT WORKED "IN A LONG, LONG TIME." 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 |
|---|---|---|---|---|---|---|---|
| 184000 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |