BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3943450 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13211
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE INS ((B)(4)) FOUND THAT THE INS SETSCREW WAS BACKED OUT TOO FAR. ANALYSIS OF THE TINED LEAD ((B)(4)) FOUND THAT THE PROXIMAL END CONNECTOR WAS PULLED OUT OR OFF.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL # (B)(4), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT # VA0J9Q5, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014; PRODUCT TYPE LEAD; PRODUCT ID 3058, SERIAL # (B)(4), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WOULD BE RETURNING THE DEVICES AS SOON AS POSSIBLE WHEN THEY RECEIVED MORE PRODUCT RETURN MAILERS. THE PATIENT WAS SCHEDULED TO HAVE A NEW IMPLANT ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY EXPECTED THE MAILERS TO ARRIVE WITHIN 2 DAYS AND THE MANUFACTURER REPRESENTATIVE WOULD LET THE MANUFACTURER KNOW ONCE THEY MAILED THE DEVICES OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423021 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention