BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7277818 · Received February 16, 2018

    Report

    Report Number
    3004209178-2018-03459
    Event Type
    Injury
    Date Received
    February 16, 2018
    Report Date
    May 3, 2018
    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
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (B)(4) FOUND NO ANOMALIES THAT WERE IDENTIFIED. IMPLANTED: (B)(6)2014 EXPLANTED:(B)(6) 2017 PRODUCT TYPE LEAD IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# UNKNOWN, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2017, PRODUCT TYPE LEAD; ADDITIONAL INFO INDICATED DEVICES EXPLANTED ON (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED A CONSUMER¿S SYSTEM WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) GAVE THE CONSUMER LITTLE EFFECT ON HER FECAL INCONTINENCE. THERE WERE HIGH LEVELS ON IMPEDANCE TEST FOR ELECTRODE 3, TRIED REPROGRAMMING WITHOUT ANY SUCCESS IN (B)(6) 2016. TESTED OLD LEAD ELECTRODE BEFORE EXPLANTATION, NO RESPONSE ON ELECTRODE 1, AND WEAK RESPONSE ON ELECTRODE 2 AND 3 WITH 1.5-1.9 MILLIAMPS. IT WAS NOTED THAT THE SURGEON FOUND DARK COLORATION IN THE LEAD INS COUPLING AND WANTED IT CHECKED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A LACK OF RESPONSE AFTER IMPLANTATION IN 2014. IT WAS NOTED THAT AFTER REPROGRAMMING IN (B)(6) 2016, THE CONSUMER GOT RESPONSE FOR 60 DAYS, AND THEN TRIED MORE REPROGRAMMING AGAIN WITH NO SUCCESS. NOTED WEAK RESPONSE ON POLE 1-2 DURING TEST AT EXPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE FOLLOWING DEVICE SETTINGS: 1.6V, 210 US, 14 HZ, C+0-, CYCLING OFF, AND BATTERY RESULTS ¿OK.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DATE OF IMPLANT WAS OCTOBER 2014, BUT THE EXACT DATE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121614 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention