BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1943897 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-10796
    Event Type
    Injury
    Date Received
    December 28, 2010
    Report Date
    December 21, 2010
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A REVISION DUE TO PREGNANCY (DATE UNK). IT WAS FURTHER REPORTED THAT THE PT CURRENTLY HAD BRUISING AND PAIN AT HER DEVICE SITE. THE PT SPOKE WITH HER PHYSICIAN ON THE PHONE AND IT WAS DISCUSSED SHE MAY NEED ANOTHER REVISION. IT WAS STATED THAT THE PHYSICIAN SUSPECTED SHE HAD A LEAD FRACTURE. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT #: V011407.| PROGRAMMER: MODEL 3037, LOT #: NJD028249N.| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT #: NJD028249N| IMPLANTED:| LEAD: MODEL 3889, LOT #: V011407