BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1870446 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07805
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 18, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO A DEPLETED BATTERY. THE PATIENT STATED IT WAS "THE THIRD TIME HE'S HAD IT REPLACED" AND THAT "THE BATTERY ONLY LASTED ABOUT A YEAR". THE PATIENT STATED HE "DID HAVE SOME OVERDISCHARGE SITUATIONS." THE PATIENT REQUESTED ANALYSIS OF HIS LAST INS. AS OF THIS REPORT, NONE OF THE PATIENT'S DEVICES HAD BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT #J0444367V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427,| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT #NFT045953P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT #NKC018336N| EXTENSION: MODEL 37083, LOT #NKC019242N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT #J0444367V| EXPLANTED:| EXPLANTED:| LOT #NFE143667H