BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4210457 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20598
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-45, LOT # VA08255, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V821945, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HIGH IMPEDANCE ISSUE. IT WAS STATED THAT ELECTRODE 4 SHOWED <(><<)>10000 IN ALL COMBINATIONS. AN IMPEDANCE TEST WAS DONE ALONG WITH REPROGRAMMING. ELECTRODE 4 WAS NOT IN USE IN ANY PROGRAM IN ANY GROUP. NO PATIENT SYMPTOM WAS REPORTED AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS LISTED AS NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONALLY, INFORMATION RECEIVED REPORTED THAT THERE WAS A HIGH IMPEDANCE ISSUE. ELECTRODES 7 AND 8 WERE >10,000 WERE SEEN. NO ACTION WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THAT ELECTRODES 7 AND 8 WERE NOT CURRENTLY NEEDED FOR EFFECTIVE PROGRAMMING. THE PATIENT WAS ALIVE, WITHOUT INJURY, AND WAS RECEIVING EFFECTIVE THERAPY. NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691843 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR