BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2182306 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05311
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER RAN THE DEFAULT IMPEDANCE AND HIGH IMPEDANCE READINGS WERE SHOWN. THE HEALTHCARE PROVIDER BELIEVED THE LEADS NEEDED TO BE REPLACED. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT# 3004209178-2011-05310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ADAPTER: MODEL# 64001, LOT# N215038| LEAD: MODEL 3387S, LOT# V020186| LOT# NKM706958H| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU142404V| PROGRAMMER: MODEL 37642 LOT# NJZ109808N| LEAD: MODEL 3387S LOT# V20088| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL# 37601| ADAPTOR: MODEL# 64001, LOT# N259675| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: