BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3297352 · Received August 20, 2013

    Report

    Report Number
    3004209178-2013-14845
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Report Date
    July 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V090728, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V091127, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DAUGHTER WAS TRYING TO READ DOCTOR'S NOTE FROM THE PATIENT'S LAST APPT., APPROXIMATELY AROUND (B)(6). IT MENTIONED "HAS ONLY ONE GOOD BATTERY" AND PATIENT WAS REDIRECTED TO HEALTHCARE PROFESSIONAL FOR PRE-SURGICAL WORKUP AND TO SEE NEUROLOGIST. THERE WERE ALSO SOME NOTES ABOUT "CUTTING DOWN THE PATCH TO 9.5ML, THEN 1/2 X'S PER MONTH". THE REPORTER WAS NOT AT HER MOTHER'S APPOINTMENT, HER SISTER WAS BUT SHE WAS UNABLE TO GET INFORMATION ABOUT THE APPOINTMENT FROM SISTER OR MOTHER. THE PATIENT HAD A FOLLOW UP APPOINTMENT SCHEDULED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER¿S REPORT # 3004209178-2013-14844.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403259 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR