INTERSTIM II
Report
- Report Number
- 3004209178-2012-10698
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Report Date
- October 26, 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
- VA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 3093-28, LOT# V741607, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).
(B)(4).
(B)(4).
IT WAS LATER REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE BLADDER INCONTINENCE NEVER STOPPED. THE PATIENT WAS INCONTINENT ALL NIGHT AND HAD TO WEAR DIAPERS AND PADS. THE PATIENT HAD BEEN BACK TO HER DOCTOR¿S OFFICE 3 TIMES TO CHECK OUT THE DEVICE AND WAS TOLD IT WAS FUNCTIONING PROPERLY. STIMULATION WAS CONFIRMED TO BE ON AND THE PATIENT FELT STIMULATION AT 4.6VOLTS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT DECIDED TO NOT SEEK FURTHER HELP. IT WAS FURTHER REPORTED THAT ON (B)(6), THE DOCTOR SAID THEY "COULDN'T KEEP" THE PATIENT. NO ADDITIONAL INFORMATION WAS REPORTED.
IT WAS REPORTED THAT PATIENT LOST THERAPEUTIC EFFECT. PATIENT HAD AGONY WITH DEVICE EVER SINCE DOCTOR PUT IT IN. PATIENT HAD PAIN IN BACK AND HIP. SYMPTOMS ARE WORSE THAN WHEN STARTED. PATIENT USED AROUND 120 PADS FOR LEAKING A WEEK AND WAS CONSTANTLY INCONTINENT. DOCTOR TOOK TWO INCHES MUSCLE FROM UPPER THIGH TO HOLD BLADDER UP, BUT IT WORKED FOR ABOUT 10 DAYS. IN ADDITION, SURGICAL MESH WAS USED, BUT DID NOT WORK. PATIENT MET WITH MEDTRONIC REPRESENTATIVE FOR REPROGRAMMING AND WITH DOCTOR STAFF, BUT DEVICE STILL NOT EFFECTIVE. PATIENT WAS CONSIDERING REMOVAL OF DEVICE. MEDTRONIC REPRESENTATIVE HELPED TO REPROGRAM DEVICE USING PATIENT PROGRAMMER, BUT IT WAS NOT COMFORTABLE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT HAD DOCTOR APPOINTMENT AND DEVICE HAS NOT WORKED SINCE SHE HAD IT PUT IN. PATIENT SAID THE RIGHT SIDE WAS AT A 3.5 CUTS OFF, AND THE LEFT SIDE WAS PAINFUL. PATIENT WAS UP AT NIGHT 2 TO 3 TIMES AND HAD BED CHUCKS. DOCTOR TRIED A CYSTO, BUT DID NOT WORK. DOCTOR SAID THAT THERE IS NOTHING MORE HE CAN DO AND THAT HE COULDN'T TAKE THE DEVICE OUT.
THE PATIENT LATER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS WORSENING EVERY TIME SHE WENT TO THE HEALTH CARE PROVIDER THAN THE TIME BEFORE. THE PATIENT STATED SHE WAS LEAKING AND WOULD LEAVE A WET SPOT BEHIND HER. THE PATIENT ALSO MENTIONED THAT THE HEALTH CARE PROVIDER TRIED TO PULL HER BLADDER UP AND WHEN SHE WENT BACK HE TOOK 2 INCHES OF LIGAMENT. THE PATIENT REPORTED THAT SHE WAS HAVING TROUBLE WHEN STANDING UP AND SITTING DOWN AND WOULD LEAVE WET SPOTS BEHIND EVEN WHEN GOING TO WORK THIS WAS BEFORE THE IMPLANT. THE PATIENT STATED DEVICE IMPLANTED IN HER WAS NO GOOD. THE PATIENT STATED 2 MONTHS AGO BLADDER WAS IN SUCH BAD SHAPE, WENT TO SEE HEALTH CARE PROVIDER CONCERNING A BOTOX. THE PATIENT THOUGHT INJECTION TO CONTROL BLADDER BUT IT WAS NOT. THE PATIENT HAD IT TURNED UP AS HIGH AS IT COULD GO IN HER. SHE CHANGED BATTERIES AND DID EVERYTHING SHE COULD DO. THE PATIENT STATED SHE COULD NOT GO ANYWHERE BECAUSE SHE WAS CONSTANTLY LEAKING FROM THE DEVICE.
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 | 00077 YR | Required Intervention |