BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3231322 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11889
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011: PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011: PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4): PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF THE PATIENT TURNED TO THE SIDE "IT KIND OF ZAPS ME, AND I HAVE TO REMEMBER NOT TO TURN SO SHARP." THE PATIENT JUST HAD IT ADJUSTED ON THURSDAY ((B)(6) 2013), AND NOTED SHE "JUST HAS TO GET USED TO IT, BUT IT IS WORKING GREAT." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332316 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR