BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3133763 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08302
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT A QUICK REPROGRAMMING FOR THE PATIENT HAD ORIGINALLY BEEN SCHEDULED. IT WAS STATED THAT THE NIGHT PRIOR TO THE APPOINTMENT THE PATIENT WAS WORRIED DUE TO NO RESPONSE FROM HER INS (IMPLANTABLE NEUROSTIMULATOR). IT WAS STATED THAT A POR WAS PERFORMED ON THE NEXT DAY, HOWEVER, IT IS LIKELY THAT PRM (PHYSICIAN MODE RECHARGE) WAS MEANT. NORMAL RECHARGING WAS THEN ACHIEVED AND THE PATIENT WAS ABLE TO RESUME THERAPY FOLLOWING THE APPOINTMENT. PATIENT SYMPTOMS WERE LOSS OF STIMULATION WHILE OVERDISCHARGED. TROUBLESHOOTING PERFORMED INCLUDED "POR, RECHARGE, AND PMR," AND CODE "0X8" WAS THEN SEEN ON THE CLINICIAN PROGRAMMER. IT WAS STATED THAT THE PATIENT RESUMED NORMAL THERAPY FROM HER INS SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POWER ON RESET (POR). IT WAS THE PATIENT¿S FIRST POR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234749 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