BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1841901 · Received September 20, 2010

    Report

    Report Number
    3004209178-2010-07110
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2010, THAT SINCE THE BATTERIES WERE REPLACED LAST MONTH PT WAS HAVING ISSUES WITH STIMULATION. HE HAD VISITED HCP THE WEEK OF (B)(6) 2010 AND CHECKING THE CLINICIAN PROGRAMMER FOUND THAT TWO CONNECTIONS WERE NOT IN THE NORMAL RANGES. PT WAS SENT FOR X-RAYS OF HIS BRAIN AND CHEST TO DETERMINE WHERE THE LEAD MIGHT BE FRACTURED. THE SYMPTOMS OCCURRED AFTER A REPLACEMENT. THE SYMPTOMS WERE AT THE LEAD LOCATION. THE PT WAS AT HOME. ON (B)(6) 2010 THE CALLER REPORTED READING >2,000 OHMS ON SOME OF THE UNIPOLAR PAIRS. PRIOR TO DEVICE REPLACEMENT PROGRAMMED TO C+, 2_. THE 0 ELECTRODE HAD REPORTEDLY NOT BEEN FUNCTIONAL FOR A COUPLE OF YEARS. AFTER DEVICE REPLACEMENT PROGRAMMED TO C+, 1-, 2-, 3- AT 3.5 V. X-RAYS WERE TAKEN AND NOTHING WAS FOUND. C,0 WERE > AND C AND 2 WERE INITIALLY >, BUT THEN HAD HIM RETRY WITH HIGHER AMP AND IT CAME DOWN, BUT STILL HIGH WITH NO THERAPY EFFECT. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE REFER TO MANUFACTURER REPORT # 2649622201007109.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UK6149771| EXTENSION: MODEL 7482, LOT# NHU153724V| LOT# NFW164414H| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UK6149770| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# V015947| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426