BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3653662 · Received February 28, 2014

    Report

    Report Number
    3004209178-2014-03769
    Event Type
    Injury
    Date Received
    February 28, 2014
    Report Date
    February 10, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA0EUAZ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V533019, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V952317, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# VA0EUAZ, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V533019, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V952317, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL AND WAS RECEIVING THERAPY AFTER THE FIRST PROGRAMMING SESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHORT. IT WAS NOTED THAT THERE WERE LOW IMPEDANCES, LESS THAN 50 OHMS ON 0<(>&<)>1 0<(>&<)>2 AND 1<(>&<)>2. ACTION REQUIRED AS A RESULT OF THE EVENT WAS REPROGRAMMING. IMPEDANCE TESTING WAS DONE. THE ISSUE WAS NOT RESOLVED AND THE CAUSE OF THE ISSUE WAS UNKNOWN. THE RIGHT LEAD WAS REPROGRAMMED TO CONTACTS NOT AFFECTED BY THE SHORT CIRCUIT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED WITH 3- <(>&<)> C+. THE PATIENT HAD TREMOR AND MODEST TREMOR CONTROL WITH NEW SETTINGS. PATIENT WAS ALIVE WITH NO INJURY AND HAD LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. THE LEAD IMPACTED BY THE SHORT WAS IMPLANTED IN THE RIGHT SUB THALAMIC NUCLEUS (STN). THE PATIENT HAD A NEW THALAMIC LEAD IMPLANTED IN THE RIGHT VENTRAL INTERMEDIATE NUCLEUS (VIM) TO BETTER CONTROL HIS TREMOR IN THE LEFT HAND ON (B)(6) 2014. SURGERY FOR THE RIGHT VIM WAS SCHEDULED PRIOR TO ONSET OF THE SHORT CIRCUIT IN THE RIGHT STN LEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ADDITIONAL INTERVENTIONS TAKEN OR PLANNED. THE PATIENT WAS NOT YET PROGRAMMED AND WOULD BE PROGRAMMED IN ABOUT 3 WEEKS OR SO FROM (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123508 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention