BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2152274 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04726
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT HAD DIFFICULTY TURNING HER DEVICE BACK ON AFTER HAVING IT OFF FOR ONE MONTH FOLLOWING A SURGERY. PATIENT STATED IT WAS CHARGED BEFORE TURNING IT OFF FOR ONE MONTH FOLLOWING A SURGERY. PATIENT STATED IT WAS CHARGED BEFORE TURNING IT OFF BUT ADMITS TO SEEING THE RECHARGE SCREEN. THE DEVICE HAD BEEN "JUMP STARTED" IN THE PAST. PATIENT REPORTED SHE FELT THE GREY WIRE ON THE RECHARGING BELT WAS SHORTING OUT. THE RECHARGER WAS UNRESPONSIVE. PATIENT HAD PROBLEMS RECHARGING AND NOTED THE RECHARGER SHOWED A LOW BATTERY WARNING SCREEN AND THEN SPLASH SCREEN. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT STATED THE SYSTEM HAD "GONE COMPLETELY OFF". IT WENT OFF AND SHE COULD NOT TURN IT BACK ON. PATIENT WANTED TO KNOW ABOUT THE PATIENT PROGRAMMER, CONTROL MAGNET RECHARGER/RECHARGING. PATIENT WAS HAVING A DIFFICULT TIME WITH THE ICONS ON HER DEVICES. FURTHER INFORMATION STATED THE PATIENT WAS NOW ABLE TO RECHARGE SUCCESSFULLY. THE PATIENT'S HCP REPORTED THE PATIENT HAD NOT BE REPROGRAMMED SINCE (B)(6) 2010. THERE WAS MENTION IN THE OFFICE NOTES FROM (B)(6) 2010 THAT THE PATIENT HAS LOST SOME EQUIPMENT. SHE SUFFERS FROM ALZHEIMER'S. HCP ALSO STATED SHE HAS AN INTRATHECAL PUMP WHICH THE PATIENT HAS FOCUSED HER ATTENTION ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR IMPLANT DATE:| LEAD: MODEL 3778, LOT #V015441| LEAD: MODEL 3778, LOT #V015441| PROGRAMMER: MODEL 37742, LOT #NJD035246N| IMPLANT DATE:| RECHARGER: MODEL 37752, LOT #NKA024772N