BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1901973 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09402
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 28, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A BURNING SENSATION AT THE LOCATION OF THE IMPLANTED NEURO STIMULATOR AND THE LEAD-EXTENSION CONNECTION SITE, WHILE STIMULATION WAS TURNED ON. DEVICE REPROGRAMMING WAS ATTEMPTED, HOWEVER, THE BURNING PAIN NEVER SUBSIDED. A LOSS OF THERAPEUTIC EFFECT WAS ALSO NOTED. THE ISSUE HAD OCCURRED FOR THE PAST 2 TO 3 MONTHS. THE PATIENT'S STATUS WAS FAIR. ON (B)(6) 2010, IT WAS FURTHER REPORTED THAT DURING A LEAD REVISION/REPLACEMENT PROCEDURE, A PHYSICIAN WAS NOT ABLE TO ADVANCE THE STYLET THROUGH A NEW LEAD. OTHER STYLETS WERE ATTEMPTED. IT WAS NOTED THAT "THE WHITE ONE WITH THE CURVED TIP WENT IN BETTER AS HE MADE IT GO THROUGH FURTHER IT BENT IT ALL UP, IT JUST WOULD NOT ADVANCE INTO THE LEAD". THE NEW LEAD WAS NOT IMPLANTED IN THE PATIENT. THE PATIENT DID NOT RECEIVE ANY REPLACEMENT DEVICES. THE PATIENT'S DEVICE/BATTERY WAS EXPLANTED EVEN THOUGH INTERROGATION AND OTHER CHECKS DID NOT INDICATED THAT THE BATTERY WAS DEFECTIVE/DEFAULTED. THE LEAD AND DEVICE/BATTERY WAS INTENDED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PT HAS RECOVERED WITHOUT SEQUELA FOLLOWING THE PROCEDURE IN WHICH THE PATIENT'S ENTIRE DEVICE SYSTEM WAS EXPLANTED.

    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 73 YR Required Intervention IMPLANTED:| STIM ACCESSORY: MODEL STYLET/RESTORE, LOT #UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT #V557249012| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/RESTORE, LOT #UNK| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT #NKB003800V| LEAD: MODEL 3888, LOT #V363467| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT #V363467| LEAD: MODEL 3778, LOT #V416779034| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #NKE139885N| EXPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA135052N