BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 3992578 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01970
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    August 1, 2013
    Report Date
    June 27, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. IN ADDITION, THE RETURNED DEVICE INDICATED A MISSING SET SCREW. THE DEVICE WAS A PART OF THE INDICATED RECALL. THE DEVICE DID ACT CONSISTENT WITH THE RECALL.

    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A BATTERY VOLTAGE OF 2.92 VOLTS AND ONE MONTH LATER WAS AT END OF LIFE (EOL) WITH A BATTERY VOLTAGE OF 2.81 VOLTS. HIGH BATTERY IMPEDANCE WAS SUSPECTED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A LOOSE SETSCREW. THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471478 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R