BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3170355 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10393
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37092, LOT # 281240002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 355028, LOT # N295272, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 355028, LOT # N295616, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DID NOT THINK THE DEVICE HAD ¿REALLY BEEN WORKING RIGHT.¿ IT WAS NOTED THAT THE PATIENT WAS INSTRUCTED TO SET UP AN APPOINTMENT FOR TROUBLESHOOTING. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 17TH 2015 INDICATING THAT THERE WAS A SUSPECTED OVERDISCHARGE. THE PATIENT HAD NOT USED STIMULATION FOR OVER A YEAR AND HAD NOT CHARGED IMPLANTABLE NEUROSTIMULATOR (INS). THE THERAPY WAS NOT HELPING THE PATIENT'S PAIN SO THEY STOPPED USING THE STIMULATION. THE PATIENT HAD LEADS BEING ON OFF LABEL PLACEMENT. THE REP WAS REQUESTING MRI GUIDELINES FOR A HEAD MRI. THE PATIENT WAS HOSPITALIZED UNRELATED TO THE DEVICE OR THERAPY. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THERE WAS A SUSPECTED OVERDISCHARGE. THIS WAS OVER A YEAR AGO. THE PATIENT HAD BEEN EXPERIENCING DIZZINESS. ON JULY 21ST 2015 THE REP INDICATED THAT THE PATIENT WAS DISCHARGE AND THAT NO ACTIONS HAD BEEN TAKEN TO RESOLVE THE LACK OF THERAPY AND SUSPECTED OVERDISCHARGE. THE CAUSE FOR LACK OF THERAPY WAS DETERMINED TO BE DUE TO NONCOMPLIANCE. ON AUGUST 7TH 2015 THE REP INDICATED THAT THEY HAD AN APPOINTMENT SET UP TO MEET WITH THE PATIENT FOR A PHYSICIAN MODE RECHARGE (PMR) BUT THE PATIENT DID NOT SHOW UP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THE PATIENT SWITCHED PAIN MANAGEMENT CLINICS. SHE WANTED TO EITHER GET HER DEVICE WORKING AGAIN OR HAVE IT REMOVED. THE REP OFFERED TO MEET WITH THE PATIENT TO DO A PHYSICIAN MODE RECHARGE (PMR). THE PATIENT HAD AN INJECTION COMING UP SOON, WAS STARTING PHYSICAL THERAPY, AND WOULD LIKELY HAVE TIME TO DO THE PMR IN DECEMBER. THE REP ASKED THE PATIENT TO CALL HIM WHEN SHE WAS READY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271054 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR