BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2082821 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03204
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 15, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PATIENT HAD REPLACEMENT SURGERY AND NO LONGER HAD PROBLEMS WITH THEIR DEVICE SYSTEM. THE HEALTHCARE PROVIDER CONFIRMED THAT THE PATIENT EXPERIENCED DECREASE RELIEF OF BACK AND RADICULAR SYMPTOMS. AN X-RAY ON (B)(6) 2010 CONFIRMED THAT ONE OF THE LEADS SHIFTED SLIGHTLY. SHE STILL HAVE GOOD COVERAGE BUT AT HIGHER VOLTAGE LEVELS. SHE DID NOT COME IN FOR REPROGRAMMING. DUE TO THE INCREASE IN POWER USED, IT CAUSED THE BATTERY OF THE INS TO DEPLETE EARLIER THAN EXPECTED. THE INS WAS REPLACED. THE SURGICAL WOUND WAS HEALING WELL AND THE INS WAS FUNCTIONING. PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE120670N| LEAD: MODEL 3776, LOT# V122118010| IMPLANTED:| LEAD: MODEL 3776, LOT# V122118009| IMPLANTED: