BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3240169 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12073
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3387 LOT# V005849, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387 LOT# V005849, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 7482 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7438 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S DEVICE SYSTEM WAS REMOVED SOMETIME IN 2006 OR (B)(6) 2007 BECAUSE IT WAS NOT WORKING SO HER PHYSICIAN DECIDED ON REMOVAL. IT WAS NOTED THE PATIENT CURRENTLY STILL HAD A LOT OF SHAKING AND TREMORS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED ALL HER COMPONENTS WERE TAKEN OUT BUT ONE WAS LEFT IN. THE PATIENT WAS TOLD IT WAS TOO DANGEROUS TO REMOVE THE COMPONENT BUT SHE DID NOT KNOW WHICH ONE. PER THE MANUFACTURER¿S DEVICE REGISTRY THE PATIENT¿S LEADS WERE NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339507 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention