INTERSTIM II
Report
- Report Number
- 3004209178-2016-00788
- Event Type
- Injury
- Date Received
- January 20, 2016
- Report Date
- September 2, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
UPON FURTHER REVIEW THE PMA P080025 APPLIES TO THIS EVENT INSTEAD OF PMA P970004. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A CONSUMER WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THINGS WERE GOING WELL AT FIRST BUT THE PATIENT RECENTLY HAD A URINARY TRACT INFECTION (UTI) THAT LASTED A MONTH WHICH WAS STRESSING OUT THE PATIENT BECAUSE SHE FELT THE TIMES SHE HAD TO GO TO VOID THE DEVICE DID NOT WARN HER SO SHE HAD ACCIDENTS. A CYST DEVELOPED NEAR THE ¿CRACK AREA¿ OF HER BACK AREA. THE PATIENT WAS CONCERNED ABOUT THE CYST AND ABOUT UTIS COMING BACK. AN APPOINTMENT WAS SCHEDULED WITHIN 2 WEEKS FROM THE CALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING CAUSE, ACTIONS, AND OUTCOME, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE DEVICE WAS WORKING BUT RECENTLY HAD A UTI THAT LASTED A MONTH. THE PATIENT WAS ALREADY WORKING CLOSELY WITH A MEDICAL DOCTOR.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT EVERYTHING WENT WELL FOR QUITE A WHILE BUT THAT THE PATIENT HAD THEIR FIRST URINARY TRACT INFECTION SINCE THE IMPLANT. THE PATIENT STATED THAT THEY HAD IT FOR PROBABLY A MONTH BUT WENT TO THE HEALTH CARE PROFESSIONAL (HCP) 10 DAYS AGO. THE PATIENT INFORMED THEIR HCP ABOUT THEIR UTI. IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED SOMETHING LIKE A BOIL, CYST, OR CARBUNCLE AT THE ¿TOP OF THE CRACK.¿ THE PATIENT HAD BEEN WORRIED ABOUT THAT. THE HCP LANCED THE PLACE WHERE THE ¿BOIL, CYST, OR CARBUNCLE¿ WAS. IT WAS STILL THERE AFTER THE HCP LANCED IT. THE PATIENT STATED THAT THEY WERE HAVING A LOT OF TROUBLE AND WERE NOT REALLY ABLE TO CONTROL THINGS. THE PATIENT HAD BEEN CONCERNED AND HAD NOT BEEN ABLE TO HOLD ANYTHING. THE PATIENT STATED THAT THEY THOUGHT THE DEVICE WOULD WARN THEM. THE PATIENT STATED THAT THEY WISHED THAT THE DEVICE WOULD WARN THEM WHEN THEY HAD TO GO FREQUENTLY BUT IT DID NOT. IT SEEMED LIKE NOTHING HELPED AT THE TIME AND THE PATIENT HAD BEEN DISTRAUGHT ABOUT IT. THE PATIENT THOUGHT THAT IT WAS DUE TO THE UTI BECAUSE IT WAS MUCH BETTER AFTER TAKING ANTIBIOTICS. THE HCP REQUESTED THAT THE PATIENT GO BACK FOR ANOTHER APPOINTMENT IN A COUPLE OF WEEKS TO RECHECK EVERYTHING. THE PATIENT WAS ALSO GOING TO GO SEE A UROLOGIST AFT ER THEIR UTI CLEARED UP SINCE BEFORE THE IMPLANT THEY HAD UTIS EVERY MONTH TO 6 WEEKS. THE PATIENT WOULD GET OFF OF THE ANTIBIOTICS AND GET ANOTHER UTI. THE PATIENT STATED THAT THE HCPS WERE VERY CONCERNED ABOUT THIS AND WANTED TO KEEP AN EYE ON THE PATIENT FOR KIDNEY AND BLADDER CANCER AS IT WAS A CONCERN WHEN THERE WERE SO MANY UTI EVENTS. THE PATIENT STATED THAT THEY DID NOT KNOW IF ¿THEY WERE GOING TO DO THAT AERODYNAMIC THING AGAIN.¿ THE PATIENT STATED THAT THEIR CURRENT UTI WAS THE FIRST ONE THEY HAD SINCE THE IMPLANT WHICH WAS WONDERFUL NEWS. THEY WERE HOPING THAT THE UTIS WOULD NOT START UP AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39674 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |