BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3122578 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07985
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7 482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V825993, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# VA07192, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF THE LEFT INS TURNING OFF WAS NOT DETERMINED; HOWEVER, THE ISSUE WAS NO LONGER OCCURRING. THE LAST TIME THE PATIENT COMPLAINED THAT THE INS WAS TURNING OFF WAS ON 2013-06-06. NO INTERVENTIONS WERE TAKEN AND NONE WERE PLANNED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE INS TURNED OFF EVERY FEW MINUTES. THE INS WOULD CLICK ON, BACK OFF, BACK ON. THERE HAS BEEN NO SPECIFIC TRIGGERS RELATED TO THIS EVENT. THERE HAVE BEEN ZERO ACTIVATIONS ON HER PRINT OUT SESSION. THE BATTERY VOLTAGE READ 3.74V. IT WAS CLARIFIED THAT INS HAS NOT BEEN WORKING FOR THE LAST TWO MONTHS. THE PATIENT EXPERIENCED BAD SHAKES, PAIN AND TREMORS. THE INS NEEDS TO BE REPLACED.

    Description of Event or Problem · 1

    THE PATIENT¿S LEFT SIDED INS KEPT TURNING OFF WHICH STARTED YESTERDAY BUT OCCURRED MOSTLY TODAY. THE INS WAS TURNED ON ALL THE TIME. SHE SAW HER DOCTOR LAST THURSDAY. SHE WOULD USE HER PATIENT PROGRAMMER TO TURN THE INS BACK ON BUT IT WOULD GO BACK OFF. THERE HAS BEEN NO FALLS OR TRAUMA. IT WAS CONFIRMED THAT THE INS WAS ON AND THE BATTERY WAS OKAY. THE PATIENT SEEMED TO BE SCARED, UPSET AND PANICKED. THE HEALTH CARE PROVIDER CONFIRMED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT DID HAVE A MRI/X-RAY ON (B)(6) 2013 WHICH DID NOT SHOW ACUTE PATHOLOGY. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY. THE PATIENT WAS SCHEDULED TO COME INTO THE OFFICE TO HAVE HER DEVICE RECHECKED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223838 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR