BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLETRA

    MDR report key: 1569477 · Received December 22, 2009

    Report

    Report Number
    3004209178-2009-09554
    Event Type
    Death
    Date Received
    December 22, 2009
    Date of Event
    January 1, 2005
    Report Date
    November 12, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CONTRALATERAL IMPLANTABLE NEUROSTIMULATOR AND EXTENSION WERE RETURNED TO THE MANUFACTURER WITH NO RETURN PAPERWORK. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATED THAT THE PT EXPIRED. ADDITIONAL INFO REQUESTED FROM THE HEALTHCARE PROFESSIONAL INDICATED THAT THE PT WAS TREATED FOR INFECTION AND WOUND DEHISCENCE IN 2005; VANCOMYCIN AND FORTAZ IV WERE ADMINISTERED. THE FOLLOWING MONTH, THE PT WAS TAKEN TO SURGERY FOR WOUND DEBRIDEMENT AND CLOSURE. THREE MONTHS LATER, THE PT WAS SEEN IN FOLLOW-UP AND THE WOUND WAS AGAIN DEBRIDED. THE PT RETURNED TWO MONTHS LATER, FOR FOLLOW-UP AND REMOVAL OF THE LEAD AND EXTENSION. THE IPG WAS REMOVED EMERGENTLY TWO MONTHS LATER, DUE TO THE SITE APPEARING INFECTED WITH ERYTHEMA AND THE PT'S SKIN BEING VERY THIN; THE LEAD/EXTENSION SITE WOUND WAS HEALING. IT WAS ALSO NOTED THAT THE PT WAS NOT EXPERIENCING ANY INCREASE IN TREMORS, SO NO REPLACEMENT WAS BEING PLANNED. THERE WAS NO MENTION OF DISPOSITION OF THE EXPLANTED COMPONENTS. THERE WAS NO FURTHER INFO AFTER THAT DATE; OUTCOME AND CAUSE OF DEATH IS UNK. SEE MANUFACTURER REPORT #6000032-2009-09242.

    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 72 YR Death EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0080022N| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNK| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# L84465| LOT#: NFW115027H| EXTENSION: MODEL 7495-51, LOT# XR0080023N| EXPLANTED:| EXPLANTED: