BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1843340 · Received September 22, 2010

    Report

    Report Number
    3004209178-2010-07162
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RECHARGER WAS BURNING THE SKIN, LEAVING A SUNBURN-LIKE AREA ON THE SKIN THAT WAS HOT TO THE TOUCH. THERE WERE NO CHANGES IN THE PATIENT'S MEDICATIONS. IT WAS NOTED THAT THE RECHARGER WAS ALSO HOT. THE THERMOMETER SIGN DID NOT APPEAR ON THE PATIENT'S RECHARGER SCREEN. THE PATIENT ONLY RECHARGED FOR THREE HOURS AT A TIME. THE RECHARGER WAS NOT WORN AT NIGHT. THE PATIENT CONSULTED WITH THE PHYSICIAN AND THE MANUFACTURER REPRESENTATIVE, WHO WERE UNABLE TO SEE A MARK ON THE SKIN AS IT HAD ALREADY HEALED. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND A LOANER DEVICE WAS SENT TO THE PATIENT. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED 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 ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR LEAD: MODEL 3777, LOT# V466273028| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V434797022| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE151359N| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA141978N