BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2864764 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02967
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS #3007566237. ADDITIONAL INFORMATION INDICATES THE CORRECT MANUFACTURING SITE ID IS (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A POCKET REVISION SURGERY ON (B)(6) 2012. IT WAS STATED THAT THERE WERE "NO DEVICE PROBLEMS" AND THE POCKET WAS "MOVED DUE TO PAIN IN THE POCKET". THE NEW POCKET WAS MADE DEEPER AND MOVED TO THE CONTRA LATERAL SIDE "WITHOUT INCIDENT". NO FURTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS TO BE A POCKET REVISION SURGERY DUE TO PAIN AT THE POCKET SITE. THE PATIENT LOST WEIGHT AND THE DEVICE WAS TOO SUPERFICIAL. THE REPORTER STATED THAT THE SURGERY WILL BE SCHEDULED FOR LATER IN THE MONTH OF (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGERY HAD TO BE RESCHEDULED DUE TO INSURANCE PROBLEMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention