BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 2367575 · Received December 12, 2011

    Report

    Report Number
    2647346-2011-01538
    Event Type
    Injury
    Date Received
    December 12, 2011
    Date of Event
    May 10, 2011
    Report Date
    September 26, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLEASE NOTE THE INITIAL REGULATORY REPORT FOR THIS REPORTABLE COMPLAINT WAS TIMELY SUBMITTED ON (B)(4) 2011 UNDER MANUFACTURING REPORT NUMBER 2183613000-2011-00376-1; HOWEVER, THE INCORRECT SUSPECT MEDICAL DEVICE WAS REFLECTED AND AS A RESULT THE REPORT REQUIRED REDACTION (WHICH WAS COMPLETED ON (B)(4) 2011). ACCORDINGLY, THIS REPORT SHOULD BE REGARDED FOR THIS REPORTABLE COMPLAINT.

    Additional Manufacturer Narrative · 1

    CORRECTED: PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #003 SHOULD HAVE BEEN SEQUENCED #001, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED: PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #003 SHOULD HAVE BEEN SEQUENCED #002, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS INDICATING "INVALID DATA." ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE CLINIC INDICATED THAT THE PATIENT WAS BROUGHT INTO THE CLINIC AND A DEVICE CHECK AND RESET WAS PERFORMED AND THE ERROR REPORTEDLY CLEARED. THE DEVICE REMAINS IN USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| O 310C29 MOSAIC PORCINE HEART VALVE| 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD| P1501DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD| 310C29 MOSAIC PORCINE HEART VALVE| P1501DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB