BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 2952141 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00096
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4). THE DEVICE WAS RETURNED AND ANALYZED. THE PRIMARY FINDINGS NOTED NO ANOMALIES WERE FOUND. THE DEVICE SETSCREW HAD A ROUNDED SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE SETSCREW OF THE DEVICE WAS CANTED WHICH RESULTED IN THE LEAD BEING UNABLE TO BE FIXED TO THE DEVICE. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57363 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR