BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2494152 · Received March 16, 2012

    Report

    Report Number
    9614453-2012-00037
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION: MODEL 748266, SERIAL: (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: NA. EXTENSION: MODEL 748251, SERIAL: (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: NA. LEAD: MODEL 3889-28, LOT: V896800, IMPLANTED: (B)(6) 2012, EXPLANTED: NA. LEAD: MODEL 3387-28, SERIAL: (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD: MODEL 3387-28, SERIAL: (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA.

    Description of Event or Problem · 1

    SEE MFR# 9614453-2012-00036. DURING A ROUTINE NEUROSTIMULATOR REPLACEMENT PROCEDURE, THE PHYSICIAN NOTED THAT AN EXTENSION SEEMED TO BE MELTED IN 2 SPOTS. ONE SPOT SHOWED THAT THE OUTER INSULATION WAS MELTED AND ONE COIL "CAME OUT"; THE AREA WAS DARKENED. IMPEDANCES WERE ABNORMAL ON THE #2 ELECTRODE. THE PHYSICIAN DECIDED TO LEAVE THE EXTENSION IN PLACE, BUT NOT USE ELECTRODE #2. IT WAS UNKNOWN WHICH NEUROSTIMULATOR WAS CONNECTED TO THE AFFECTED EXTENSION (BILATERAL SYSTEMS IN PLACE). ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY WHICH EXTENSION/SYSTEM WAS AFFECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICAGTED IT WAS UNKNOWN WHICH INS WAS CONNECTED TO THE AFFECTED EXTENSION. THE AFFECTED EXTENSION WAS SERIAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR