BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3123898 · Received May 22, 2013

    Report

    Report Number
    6000032-2013-00132
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT # J0120822V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # J0118540V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN BOTH DEVICES ARE ON THE PATIENT ¿WALKS FUNNY.¿ THIS HAS BEEN GOING ON SINCE THE SECOND DEVICE WAS IMPLANTED. SHE USUALLY ONLY HAS ONE DEVICE TURNED ON. IT WAS KNOWN THAT THE LEAD WAS ¿MISPLACED¿ (NOT IN THE RIGHT SPOT) AND NOT IN THE VIM. IN 2007 THE PATIENT HAD ANALYSIS BY A NEUROLOGIST WITH A MRI WHICH SHOWED THE LEAD WAS SLIGHTLY OFF POSITIONED IN THE BRAIN WHICH CAUSED THE WALKING TROUBLE. THE DEVICE DOES WORK GREAT FOR HER HANDS AND TREMOR. SHE DOES REALLY WELL BOTH DEVICES AND ONLY USES THERAPY WHEN SHE WAS HOME BUT NOT WHEN SLEEPING. THE BATTERY LONGEVITY CALCULATED >120 MONTHS FOR THE RIGHT SIDE. IMPEDANCE MEASUREMENTS WERE 834OHMS. THE PATIENT WAS NOT INTERESTED IN A REVISION AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226027 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7426

    Patients

    Seq Age Sex Outcome Treatment
    1