BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2141136 · Received June 22, 2011

    Report

    Report Number
    3004209178-2011-04650
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 26, 2011
    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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HAVING DIFFICULTY WITH RECHARGING HER IMPLANTED NEUROSTIMULATOR (INS). THE PT WAS NOT ABLE TO GET ANY COUPLING BARS. IT WAS NOTED THAT THE POCKET SITE WAS SWOLLEN. THE ANTENNA LOCATE FEATURE WAS ATTEMPTED WITH THE HIGHEST RESULT AROUND 30. CHARGING WAS ATTEMPTED WITH A DIFFERENT RECHARGER, BUT WAS UNSUCCESSFUL. THE PT HAD NOT BEEN ABLE TO OBTAIN COUPLING SINCE IMPLANT. IT WAS NOTED THAT THE INS WAS ABLE TO INTERROGATE WITH THE CLINICIAN PROGRAMMER AND THE PT PROGRAMMER. ON (B)(6) 2011, A POCKET REVISION TOOK PLACE; THE PHYSICIAN AND PT DECIDED TO REPLACE THE INS AS THEY BELIEVED IT WAS FAULTY. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention LEAD: MODEL 39286-65, LOT# V603726036| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA149306N| IMPLANTED:| EXPLANTED:| EXPLANTED: