INTERSTIM II
Report
- Report Number
- 3004209178-2019-13863
- Event Type
- Malfunction
- Date Received
- July 19, 2019
- Date of Event
- July 2, 2019
- Report Date
- August 8, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- UDI-DI
- 00613994913654
- PMA / PMN Number
- P080025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR. REP SAID THEY WERE USING THE SMART PATIENT PROGRAMMER (PP) AND NOTED ALL CONTACTS WERE GREEN EXCEPT CONTACT 1 WHEN THEY WERE INTRA-OPERATIVE; MOTOR RESPONSE WAS ALSO GOOD. POST-OPERATIVE, THEY NOTED THAT THE PATIENT FELT STIMULATION AND ALL CONTACTS WERE GREEN. THE REP THEN SAID THE BIPOLARS WERE ALL >4000 OHMS AND THE CASE VALUES WERE NORMAL WHEN THEY CHECKED IMPEDANCES POST-OPERATIVE. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IN RESPONSE TO THE INQUIRY FOR CAUSE THE REP REPORTED THAT THERE WAS NO KNOWN CAUSE OF THE ISSUE. ON (B)(6) 2019, THE REP REPLIED THAT THE ISSUE HAD BEEN RESOLVED AND THAT THE INFORMATION WAS CONFIRMED WITH THE HEALTH CARE PHYSICIAN (HCP) OFFICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603153 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | 00613994913654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |