2182207-2021-02220
Report
- Report Number
- 2182207-2021-02220
- Event Type
- Injury
- Date Received
- December 22, 2021
- Date of Event
- December 9, 2021
- Report Date
- December 22, 2021
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT WAS SET TO PROGRAM 1 AT .9 OR .7V WITH THE DOCTOR. ALL OF A SUDDEN NOTHING WAS HELPING AND THEY WERE GETTING PAIN LIKE HAD A BLADDER INFECTION. THEY WOULD RUN TO BATHROOM AND NOTHING WOULD COME OUT. THE ISSUE STARTED LAST THURSDAY DECEMBER 9 AND THEY CALLED THE DOCTOR ON FRIDAY DECEMBER 10. THE DOCTOR DID A URINE TEST AND IT CAME BACK MONDAY NEGATIVE FOR UTI. IT WAS MENTIONED TO CHECK THE PROGRAMMING OF THE STIMULATOR. THE PATIENT CHECKED THEIR SETTINGS AND THE HANDSET HAD CHANGED TO A NEW SETTING, PROGRAM 4 AT 1.7V. THEY DIDN'T KNOW HOW IT CHANGED. THE PATIENT RESET IT BACK TO PROGRAM 1 AT .7V ON MONDAY MORNING. THEY WANTED TO KNOW HOW THE HANDSET CHANGED THE SETTINGS. PATIENT SERVICES EXPLAINED THAT THEY DON'T KNOW WHAT CHANGED THE SETTINGS, BUT TOLD THE PATIENT THEY DID THE RIGHT THING BY SETTING THE PROGRAMMING BACK. THE PATIENT'S PAIN STOPPED ABOUT AFTER THREE DAYS OF RESETTING THE PROGRAM AND AMPLITUDE. THEY ARE BETTER AND DON'T HAVE URGENCY PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1956785 | EZW | MEDTRONIC NEUROMODULATION | A520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Other |