BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6771019 · Received August 7, 2017

    Report

    Report Number
    3004209178-2017-16325
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    January 2, 2017
    Report Date
    September 22, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND THE OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28 LOT# V913913 SERIAL# IMPLANTED: 2012 (B)(6) EXPLANTED: 2017 (B)(6) PRODUCT TYPE LEAD . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28, LOT# V913913, IMPLANTED: (B)(6) 2012, EXPLANTED:(B)(6 2017), PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REP. IT WAS REPORTED THAT THEY COULDN'T KNOW THE CAUSE OF THE OUT OF RANGE IMPEDANCES FOR CERTAIN, BUT THEY SUSPECTED THE MOTOR VEHICLE ACCIDENT (MVA) WAS THE CAUSE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING THE PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULTOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE REP REPORTED THAT THE PATIENT STATED THAT THEY HAD SYMPTOM RETURN FOLLOWING A MOTOR VEHICLE ACCIDENT THAT OCCURRED IN (B)(6) 2017. THE DEVICE WAS CHECKED IN THE PHYSICIAN¿S OFFICE AND IMPEDANCES WERE OUT OF RANGE. IT WAS INDICATED THAT SURGICAL INTERVENTION OCCURRED ON (B)(6) 2017 TO REPLACE THE LEAD AND BATTERY WHICH RESOLVED THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED OR WERE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552334 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention