BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3591792 · Received January 24, 2014

    Report

    Report Number
    3004209178-2014-01154
    Event Type
    Injury
    Date Received
    January 24, 2014
    Report Date
    January 3, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V192123, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V902684, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RECENTLY THE PATIENT'S BATTERY "WENT OUT" AND IT WAS REPLACED. SHE HAD SEEN THE HCP (HEALTH CARE PROFESSIONAL) BETWEEN (B)(6) 2013 AND WAS TOLD THE BATTERY WAS FINE AND HAD A GREAT CHARGE. IT WAS STATED THAT "SUDDENLY" THE INS (IMPLANTABLE NEUROSTIMULATOR) "WENT OUT" AND THERE WAS "NO PHASING OUT." IT WAS STATED THAT THE PATIENT WAS WONDERING IF THAT COULD BE DUE TO USING A VIBRATOR. THE INS WAS REPLACED IN (B)(6) 2013. IT WAS ALSO NOTED THAT WHEN SHE USED THE VIBRATOR BEFORE, SHE GOT A "SHOCKING FEELING" BY HER INS. HER INS WAS IMPLANTED IN HER ABDOMEN. THIS HAPPENED THE OCCASIONAL TIME SHE USED THE VIBRATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56604 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention