BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4852516 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11804
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387-40, LOT# J0340363V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0519661V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_RECHARGER_ACC, PRODUCT TYPE: RECHARGER.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT INJURY. THE PATIENT HAD A FALL AND HAD FRACTURED HER LEFT HAND. THE PATIENT HAD STATED THAT IT GOT BRUISED AND BANGED UP. THERE WAS A LOSS OF THERAPEUTIC EFFECT; THE PATIENT¿S TREMOR HAD RETURNED IN THEIR RIGHT HAND. THE PATIENT HAD BEEN UNABLE TO ADJUST STIMULATION AND THE PATIENT PROGRAMMER WAS SHOWING A ¿CALL YOUR DOCTOR¿ ICON AND A POWER ON RESET (POR) CONDITION. THE PATIENT WAS ABLE TO CLEAR THE POR AND TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) ON AND FELT STIMULATION AGAIN. THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. THE PATIENT SAW AN END OF SERVICE (EOS) MESSAGE ON (B)(6) 2015 AND HAD NO CONTROL OF HER RIGHT ARM. THE PATIENT WAS HAVING PROBLEMS WITH THE STIMULATOR AND THE RECHARGER. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396319 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR