BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2950924 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00433
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    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 NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES AND THE PATIENT EXPERIENCED A JOLTING SENSATION AT THE DEVICE POCKET. THE REPORTER STATED THAT THE IMPEDANCE SHOWED AN OPEN CIRCUIT AND THE EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE REPLACED. IT WAS NOTED THAT THE ISSUE WAS LOCATED AT THE DEVICE POCKET AND SYMPTOMS INCLUDED PAIN AND LESS THAN 50% THERAPY RELIEF. THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS FEELING FINE POST-OPERATIVELY. THE REPORTER STATED THAT IMPEDANCES WERE OKAY, NO PROBLEMS WERE FOUND, AND WHEN THE DEVICE WAS TURNED ON THE PATIENT DID NOT EXPERIENCE ANY JOLTING SENSATION. IT WAS REPORTED THAT THE PATIENT WAS FEELING FINE AND WAS GETTING THERAPY AGAIN WITHOUT ANY UNCOMFORTABLE SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54676 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention