BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1864456 · Received October 6, 2010

    Report

    Report Number
    3004209178-2010-07643
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    June 1, 2010
    Report Date
    March 30, 2018
    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
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INS WAS LAST FULLY RECHARGED IN (B)(6)2010. BY (B)(6)2010, THE DEVICE WAS NOT RECHARGING. THE PATIENT WAS TO SEE THE PHYSICIAN ON (B)(6)2010. THE PATIENT'S INS WAS REMOVED AND REPLACED ON (B)(6)2010. THERE WAS NO MALFUNCTION IDENTIFIED WITH THE REPLACED INS DEVICE. THE PATIENT WENT THREE TIMES, EACH MORE THAN 90 DAYS IN LENGTH, WITHOUT RECHARGING THE DEVICE. THE PATIENT DID NOT MEET WITH THE MANUFACTURER REPRESENTATIVE TO DISCUSS ANY ISSUES. THE PATIENT WAS REPORTED TO BE "HAPPY," FOLLOWING THE REPLACEMENT. NO FURTHER DETAILS WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention "SEE H10...."| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V002829| LEAD: MODEL 3778, LOT# V003646| PROGRAMMER: MODEL 37742, LOT# NJD020878N| LEAD: MODEL 3778, LOT# V003646| LEAD: MODEL 3778, LOT# V002829| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD020878N| IMPLANTED: