BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 3861496 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01443
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: THE DEVICE WAS RETURNED AND ANALYZED. PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TEST ING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2013 THE DEVICE BATTERY SHOWED LONGEVITY OF 1-28 MONTHS. IN (B)(6) 2014, THE PATIENT WAS TRAVELING TO THE ROUTINE DEVICE CHECK. AS SOON AS THE PATIENT GOT OFF THE PLANE, THEY EXPERIENCED, DIAPHORESIS, PRE-SYNCOPE AND ARRIVED AT THE HOSPITAL WITH A PULSE RATE OF 20 BEATS PER MINUTE, UNREADABLE BLOOD PRESSURE, EXTREME DIAPHORESIS AND CHEST PAIN. THE DEVICE WAS AT END OF LIFE (EOL) AND INTERROGATION OF THE DEVICE WAS NOT POSSIBLE AS IT WAS NOT WORKING. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343009 SIGMA 200 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SDR203U35X

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| L| R