INTERSTIM II
Report
- Report Number
- 3004209178-2012-09215
- Event Type
- Malfunction
- Date Received
- October 16, 2012
- Report Date
- September 17, 2012
- 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
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID 3093-28, LOT# V552242, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.
IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST THE STIMULATOR. THE PATIENT SAW THE PATIENT PROGRAMMER DISPLAYED 'CALL YOUR DOCTOR' ICON. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT FOLLOWING A SURGERY ON (B)(6) 2012 AND THEY DISCOVERED AT THAT TIME THAT HER BLADDER 'FELL DOWN' AND THE PATIENT HAD NOT GOOD THERAPEUTIC EFFECT SINCE THEN. THE PATIENT STATED THAT SHE WAS CATHETERIZED WHILE IN THE HOSPITAL. THE PATIENT ATTEMPTED TO ADJUST STIM PROGRAM SETTINGS AND DID NOT SEE RESULTS. THE PATIENT HAD AN ULTRASOUND ON FRIDAY, (B)(6) 2012 TO CHECK HER BLADDER AND THEN SAW POR MESSAGE ON THE PATIENT PROGRAMMER THE NEXT DAY. THE PATIENT HAD INTERSTITIAL CYSTITIS. THE PATIENT SPOKE TO THE MANUFACTURER'S REPRESENTATIVE ABOUT THE POR ON HER PROGRAMMER. THE CAUSE OF THIS EVENT WAS UNKNOWN. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2012 WAS 'UNREMARKABLE.' BLADDER'S SCAN ON '(B)(6) 2010' RESIDUAL 240 CC. THE PATIENT SYMPTOM WAS PAIN. THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00047 YR |