BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1760494 · Received July 15, 2010

    Report

    Report Number
    3004209178-2010-05521
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    THE PT'S LEAD WAS REVISED. THE PT HAD PREVIOUSLY HAD HIS LEADS REMOVED AND HIS IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLUGGED. IT WAS BELIEVED THAT THIS WAS DUE TO POOR STIMULATION COVERAGE. DURING THE REVISION, THE PHYSICIAN WAS UNABLE TO REMOVE THE PLUG; HE ENCOUNTERED RESISTANCE WHEN TRYING TO PULL IT OUT. THE PHYSICIAN DID USE THE APPROPRIATE WRENCH. THE PHYSICIAN WAS TOLD THAT IF HE PULLED TOO HARD IT COULD SNAP. THE PLUG SNAPPED IN TWO. THE REMAINING PIECE OF THE PLUG WAS STILL IN PT. A NEW INS WAS IMPLANTED. THE PT DID NOT SUFFER ANY ADVERSE EFFECTS FROM THIS PROCEDURE AND WAS DOING WELL WITH THE NEW LEADS AND INS.

    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 48 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA129608N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE128778N| STIM ACCESSORY: MODEL 3550-29, LOT# N209642| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39286-65, LOT# N216676001| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNK| IMPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNK| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N217695| STIM ACCESSORY: MODEL WRENCH, LOT# UNK