BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2854860 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11079
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    June 2, 2016
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377745, LOT# V002679, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY ¿PROBABLY¿ GET 50% RELIEF AND THAT THEY HAD FALLEN A NUMBER OF TIMES OVER THE YEARS. THE PATIENT STATED THAT THEIR BACK WAS BOTHERING THEM. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A "WARM SENSATION" IN OR AROUND THE DEVICE POCKET DURING RECHARGING. IT WAS FURTHER REPORTED THAT THE PATIENT'S CHARGER HAS BEEN GETTING "REALLY HOT" THE LAST COUPLE OF WEEKS. IT WAS NOTED THAT THE PATIENT'S SKIN "LOOKED BURNT, DISCOLORED." IT WAS ALSO NOTED THAT COUPLING HAD DECREASED. IT WAS STATED THAT THE PATIENT WAS GETTING "4-5 COUPLING BARS AT BEST, BUT IT WOULD GIVE HER LESS." IT WAS FURTHER NOTED THAT THE PATIENT DOES NOT STOP CHARGING DESPITE THE HEAT. THE PATIENT HAS REPORTEDLY NOT DROPPED THE RECHARGER OR GOTTEN IT WET. THERE WAS ALSO "NO POCKET ISSUE." IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT GETTING "AS MUCH PAIN RELIEF" FOR THE LAST 1-2 YEARS. THE PATIENT STATED THAT "IT EVEN GOT WORSE AFTER A MANUFACTURE REPRESENTATIVE CHECKED HER IMPLANT ON (B)(6) 2012. IT WAS NOTED THAT STIMULATION WAS STILL IN THE SAME AREA, BUT THE PAIN RELIEF WAS NOT AS GOOD. THE PATIENT WAS NOT ABLE TO ELABORATE BEYOND "IT DOESN'T WORK AS GOOD." THE PATIENT'S HEALTH CARE PROVIDER (HCP) REPORTEDLY HAD THOUGHT SHE "MIGHT NOT BE GETTING THE RIGHT CONNECTION, MEANING THE LEAD MAY HAVE MOVED." THAT SAME DAY IT WAS REPORTED THAT THE RECHARGER HAD NOT HAD A PREVIOUS COMPLAINT OF "OVER TEMPERATURE. " APPROXIMATELY A WEEK LATER IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF PAIN RELIEF SHORTLY AFTER IMPLANT. IT WAS ALSO NOTED THAT THE PATIENT HAD FALLEN "A COUPLE OF TIMES." THE PATIENT STATED THAT "TECHNICIANS HAVE SCREWED UP HER PROGRAMMING IN THE PAST." IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN "MUCH WORSE" SINCE SHE LAST SAW A NURSE. THE PATIENT REPORTEDLY TOLD THE NURSE NOT TO MAKE CHANGES AND THE NURSE CHECKED THE BATTERY. IT WAS ALSO REPORTED THAT THE PATIENT WAS STILL HAVING TROUBLE WITH THE RECHARGER GETTING TOO HOT WHILE RECHARGING AND SHE WAS HAVING COUPLING ISSUES. IT WAS NOTED THAT THE PATIENT HAD RECEIVED A NEW RECHARGER ABOUT A WEEK PRIOR TO THE REPORT. IT WAS ALSO NOTED THAT THE PATIENT'S HEALTH CARE PROVIDER'S OFFICE "KEPT SAYING THAT SHE MUST HAVE FALLEN." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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