BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2862460 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11320
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT DID NEED A LEAD REVISION BECAUSE HIS LEADS HAD SHIFTED. CALLER STATED SHE WAS NOT AWARE OF ANY PROBLEMS WITH THE BATTERY, OR ITS REPLACEMENT BECAUSE IT WAS JUST REPLACED IN 2011. LEAD REVISION HAD NOT BEEN SCHEDULED AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT STILL HAD CONCERNS REGARDING HIS DEVICE BUT WAS WORKING WITH HIS DOCTOR OR MANUFACTURER REPRESENTATIVE. NO APPOINTMENT DATES WERE REPORTED. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT SOUGHT FURTHER HELP. IT WAS STATED THAT "NOBODY SEEMED TO CARE ABOUT THE PROBLEM" AND THAT THE PATIENT "WAS GOING TO FIND A BETTER SOLUTION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE BATTERY WAS DEPLETING PREMATURELY. THE REPORTER STATED THAT FOR 6 MONTHS THE PATIENT CHARGED FOR 6 HOURS WITH 8 (OF 8) COUPLING BARS OF EFFICIENCY AND ONLY GOT 80% OF THE BATTERY FULL. IT WAS REPORTED THAT IF HE DOESN'T USE THE DEVICE FOR A DAY THE BATTERY SHOWS 25% LEFT. THE REPORTER STATED THAT WHEN THE PATIENT DOES USE THE DEVICE THE BATTERY DEPLETES "VERY RAPIDLY IN A MATTER OF HOURS." IT WAS REPORTED THAT THE DEVICE MAY HAVE BEEN ON HIGH SETTINGS BUT THE PATIENT DIDN'T KNOW WHAT THEY WERE. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE REPORTER STATED THAT THE RECHARGER WAS NOT CHARGING. ADDITIONAL INFORMATION HAS BEEN 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 ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1