BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3192371 · Received June 27, 2013

    Report

    Report Number
    6000032-2013-00158
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 5, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT# J0217201V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT# J0217061V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IN MFR # 6000032-2013-00157, THE SAME INFORMATION AS IN THIS REPORT WAS STATED. ADDITIONAL REVIEW INDICATES THIS INFORMATION ONLY PERTAINS TO THIS MANUFACTURER¿S REPORT. ANY ADDITIONAL INFORMATION RELATED TO THE LOSS OF THERAPEUTIC EFFECT ON THE RIGHT SIDE EVENT WILL BE REPORTED IN THIS REPORT. RIGHT-SIDE SYMPTOMS WERE REPORTED, WHICH WOULD BE LINKED TO THE LEFT INS (IMPLANTABLE NEUROSTIMULATOR), AND THERE WAS NO EVIDENCE TO SUGGEST THAT THE RIGHT INS WAS INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT HAD A CT SCAN 5 OR 6 DAYS PRIOR TO REPORT AND SINCE THEN THEIR RIGHT SIDE WAS ¿KIND OF SHAKY¿ AND IT HAD NOT BEEN SHAKY BEFORE THE SCAN. IT WAS NOTED THE PATIENT TRIED TURNING THEIR STIMULATION OFF AND BACK ON AND THEIR RIGHT SIDE WAS STILL SHAKY, ESPECIALLY IN THEIR HAND. REPORTEDLY, THE PATIENT SLICED THEIR FINGER WHEN TRYING TO PUT A CHECK IN AN ENVELOPE. IT WAS STATED THE PATIENT¿S SYMPTOMS HAD GOTTEN WORSE IN THE PAST, BUT NOT AS BAD AS AT THE TIME OF REPORT. IT WAS NOTED THE PATIENT DID NOT TURN THEIR DEVICE OFF BEFORE THE CT SCAN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. REFERENCE MANUFACTURER REPORT # 6000032-2013-00157.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292548 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR