BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1962875 · Received January 13, 2011

    Report

    Report Number
    3004209178-2011-00343
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2009
    Report Date
    December 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2009, THEY WERE UNABLE TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) USING THE PHYSICIAN PROGRAMMER, RECHARGER AND THE PT PROGRAMMER. AN INS OVERDISCHARGE WAS SUSPECTED; THE PT HAD NOT CHARGED THE INS SINCE THE SUMMER DUE TO HEALTH ISSUES. AN X-RAY CONFIRMED THE INS WAS NOT FLIPPED. IN (B)(6) 2010, THE INS WAS OVERDISCHARGED. THE PT WAS TO CHARGE THE BATTERY; HOWEVER, ONE WEEK LATER, THEY WERE HAVING COUPLING AND/OR COMMUNICATION ISSUES WITH THE INS. AN INS OVERDISCHARGE WAS AGAIN SUSPECTED. THE PT HAD BEEN HAVING COUPLING ISSUES WHILE TRYING TO RECHARGE; IT WAS THOUGHT THAT THIS WAS THE PRIMARY REASON FOR THE OVERDISCHARGE. IT WAS NOTED THAT THE PT WOULD BE GETTING A POCKET REVISION THE NEXT MONTH BECAUSE OF THE LOW/POOR COUPLING. IT WAS LATER REPORTED THAT THE PT WAS IMPLANTED WITH A NEW INS IN (B)(6) 2010 AND THE REPORTER HAD HEARD OF NO FURTHER PROBLEMS SINCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V022081030| IMPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N111045002| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V022647013| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB016118V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB016143V| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD040884N| EXPLANTED: