BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2191005 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-05563
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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 DURING A ROUTINE INTERROGATION IMMEDIATELY FOLLOWING REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR, IMPEDANCE READINGS WERE >10,000 OHMS ON ELECTRODE PAIR 6 AND 7. THE LEADS HAD NOT BEEN REPLACED. THERE WAS NO PT INJURY, AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 377025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR LEAD: MODEL 3778, LOT# V539250014| EXTENSION: MODEL 37081, LOT# NJB057528V| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V420729006| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB057529V| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE155671N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: