BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7541767 · Received May 24, 2018

    Report

    Report Number
    3007566237-2018-01552
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 22, 2018
    Report Date
    May 30, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

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

    Description of Event or Problem · 1

    ON (B)(6) 2018, (B)(4): INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE REP REPORTED THAT THE DOCTOR DOES NOT CHECK IMPEDANCES IN THE OR AFTER CONNECTION. THE CALLER STATES THAT MOTOR RESPONSE WAS OBSERVED BELOW 1.5 AND CALLER LATER SAID IT WAS AT 0.3. AFTER THIS THE CALLER USED THE 3037 TO INCREASE THE STIM TO 4 AND THE PATIENT DID NOT FEEL ANYTHING. SHE THEN USED HER 8840 TO CHECK IMPEDANCES AND PATIENT JUMPED OUT OF THE CHAIR. C2, C3, 02, 03, 12, 13, 23, WERE ALL OVER 4K. C0 516, C1 563, 01 1016. NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED BY THE REPRESENTATIVE THAT THE PATIENT COULD NOT FEEL STIMULATION AT 4 AMPS WHEN CHECKING THE FIRST 4 PROGRAMS/ CONFIGURATIONS C1,C2,C3 AND C4 BUT THAT STIMULATION WAS FELT AT LOW AMPS WHEN CHECKING IMPEDANCE AND REPROGRAMMING THE IPG TO USING 0-1+, C+0-, C+1-. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385068 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR