BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2230423 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06330
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN END OF SERVICE/END OF LIFE MESSAGE. IT WAS RECOMMENDED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BE REPLACED. THE PT WAS IN THE HCP OFFICE 2 WEEKS PRIOR AND THE HCP CONFIRMED THE INS BATTERY WAS DEPLETED. THE PT ALSO REPORTED CRAMPS IN HER HIP AT THE INS SITE. IT WAS REPORTED THAT THE INS WAS REPLACED ON (B)(6) 2011 AND THE POCKET REVISED FOR MORE OPTIMAL PLACEMENT OF THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention EXPLANTED:| LEAD: MODEL 3080, LOT# L69328| PROGRAMMER: MODEL 3037, LOT# NJD082191N| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH003251V| EXPLANTED:| IMPLANTED:| EXPLANTED: