INTERSTIM II
Report
- Report Number
- 3004209178-2017-22341
- Event Type
- Injury
- Date Received
- October 23, 2017
- Date of Event
- October 19, 2017
- Report Date
- February 22, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS OF THE INS, MODEL 3058, SERIAL NO. (B)(4), FOUND INS BATTERY NORMAL END OF LIFE, NO TELEMETRY AND NO OUTPUT, NO SIGNIFICANT ANOMALY. THE INS CAN WAS DENTED AND THE SETSCREW WAS BACKED OUT TOO FAR. ANALYSIS OBSERVED NO OUTPUT OR TELEMETRY ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND DETERMINED NORMAL BATTERY DEPLETION. A LAB FUNCTIONAL TEST DETERMINED THAT NO OUTPUT WAS OBSERVED ON ANY ELECTRODE PAIR. ANALYSIS DETERMINED THAT NO TELEMETRY WAS OBSERVED WITH AN N'VISION CLINICIAN PROGRAMMER. A COMPUTER LONGEVITY ESTIMATE WAS COMPLETED BASED ON THE INFORMATION OBTAINED FROM THE RETURNED PRINTOUT. BASED ON THIS INFORMATION THE INS REACHED A NORMAL LOW/EOS CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED INABILITY TO COMMUNICATE WITH A CONSUMER¿S IMPLANTABLE NEUROSTIMULATOR (INS), WHICH OCCURRED DURING NORMAL USE. IT WAS NOTED THAT THE CONSUMER WAS UNABLE TO OPERATE THE INS WITH HIS PATIENT PROGRAMMER (PP). THE MESSAGE WITH THE DOCTOR APPEARED ON THE PP WITH POR (POWER ON RESET) AND ¿!¿ IN THE TRIANGLE IMAGE APPEARED. THE CONSUMER LOST SENSATION OF THE STIMULATION. NO ISSUES WERE REPORTED REGARDING FACTORS THAT COULD HAVE LED TO THE REPORTED EVENT. THE CONSUMER REGULARLY COMMUNICATED WITH THIS PP AND INS ONCE PER WEEK AND EXPERIENCED NO PROBLEM OR OTHER SIGN THAN NORMAL BEFORE THIS EVENT. AN APPOINTMENT WITH THE HCP ON (B)(6) 2017 FOUND NO RESPONSE FROM THE INS FROM WITH THE PP AND THE CLINICIAN PROGRAMMER (CP). THE HCP WAITED 15 MINUTES AND TRIED AGAIN, AND AGAIN THERE WAS NO SUCCESS WITH COMMUNICATION. THE HCP DISCUSSED WITH THE CONSUMER FOR A REPLACEMENT TO TAKE PLACE AS SOON AS POSSIBLE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE CONSUMER¿S MEDICAL HISTORY INCLUDED URGE RETENTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A REPLACEMENT SURGERY TOOK PLACE AND THE DEVICE WAS REPLACED BY A NEW ONE. THE EXPLANTED BATTERY WAS RETURNED. THERE WAS A COMMUNICATION WITH THE BATTERY ON THE (B)(6) 2016 WHICH SHOWS LOW BATTERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. SETTINGS WERE NOTED AS 3.3 V, 420 PULSE WIDTH, 31 HZ, C+1-, THERAPY IMPEDANCE WAS 1063 OHMS, AND CYCLING WAS OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747879 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |