BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2251158 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07572
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY WITH RECHARGING THE PULSE GENERATOR. ADDITIONAL INFORMATION RECEIVED REPORTED AN ERROR MESSAGE OCCURRED AFTER INTERROGATING THE PULSE GENERATOR. THE CODE RELATED TO "STRONG ELECTROMAGNETIC INTERFERENCE OCCURRENCE" WAS RECEIVED. THERE WERE NO SIGNS OR SYMPTOMS. THE ERROR MESSAGE WAS CLEARED. THE PATIENT RESOLVED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V007225| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# UNKNOWN| PROGRAMMER: MODEL 37742, LOT# NJD022180N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V007225