BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK INTERSTIM

    MDR report key: 2250727 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07700
    Event Type
    Injury
    Date Received
    September 12, 2011
    Report Date
    August 24, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A WARM FEELING AND SWELLING AT THE POCKET. THERE WERE RED MARKS OVER THE LEADS. ON (B)(6) 2011 THE PT HAD SEVERE PAIN AND PRESSURE OVER THE POCKET. THE PT HAD INTERMITTENT SORENESS OVER THE INCISION FOLLOWING A REPLACEMENT IN (B)(6) 2011. THE PT THOUGHT SHE HAD AN INFECTION AND WENT TO THE ER WHERE SHE WAS TOLD "IT WAS FINE", BUT SHE WAS PRESCRIBED AN ANTIBIOTIC. THE ISSUE STARTED TO GET BETTER, BUT THEN STARTED GETTING BAD AGAIN. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INTERSTIM EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER: MODEL 3037, LOT #NJD057901N| LEAD: MODEL 3093, LOT #V066806| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT #NJY111044H| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,