BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM DR

    MDR report key: 4832326 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01120
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    January 14, 2015
    Report Date
    March 24, 2015
    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
    JA
    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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A FULL ELECTRICAL RESET. CRITICAL RAM PARITY ERROR OCCURRED IN ADDRESS OF (B)(4) ON (B)(4) 2015. POR SEVERITY IS LOW, SO THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. PATIENT WAS WITHIN 2 METERS OF A MICRO-WAVE THERAPEUTIC INSTRUMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POWER ON RESET (POR). IT WAS NOTED THERE WAS A "MICRO-WAVE THERAPEUTIC INSTRUMENT NEARBY THE REHABILITATION EQUIPMENT WHICH THE PATIENT USED" AND THERE WAS ELECTROMAGNETIC INTERFERENCE (EMI). IN ADDITION, THE IPG EXHIBITED "UNUSUAL INSTABILITY" IN BATTERY IMPEDANCE MEASUREMENTS. THE IPG WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375275 ENRHYTHM DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention 5554-45 LEAD, 5054-52 LEAD