BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1172104 · Received September 18, 2008

    Report

    Report Number
    3004209178-2008-05891
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFICACY AFTER GOING THROUGH AIRPORT SECURITY. PT CONFIRMED THERE WAS AN UNSPECIFIED ISSUE WITH THE THERAPY USING THE PT PROGRAMMER. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT# 3004209178-2008-05890.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANTED:| LEAD: MODEL UNK| IMPLANTED:| LEAD: MODEL UNK| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT# NFW149662H| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| EXTENSION: MODEL 7482