BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3990392 · Received August 7, 2014

    Report

    Report Number
    3008973940-2014-00282
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT TRIGGERED FALSELY. THE ANALYST NOTED THAT FALSE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIGGERED ON (B)(6) 2013 AND BATTERY VOLTAGE WAS NOT AVAILABLE DUE TO MEASUREMENT SYSTEM LOCK-UP. A RESET OF THE DEVICE BY PROGRAMMER WITH UPDATED SOFTWARE CLEARED THE LOCK-UP CONDITION.

    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

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARDWARE ISSUE HAD OCCURRED WITH THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) DURING A MEASUREMENT AND THAT THE DEVICE HAD LOCKED UP. AS A RESULT, THE DEVICE FALSELY INDICATED THAT THE BATTERY HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE LEVEL AND SUBSEQUENTLY DEFAULTED TO ERI PROGRAMMING OF VVI MODE AND A PACING AT A RATE OF 65 PULSES PER MINUTE. DURING A SUBSEQUENT DEVICE INTERROGATION, THE PROGRAMMER SOFTWARE WAS ABLE TO UNLOCK THE DEVICE; HOWEVER, THE BATTERY VOLTAGE MEASUREMENT VALUE WAS NOT UPDATED AND DISPLAYED AS "VOLTAGE NOT AVAILABLE". AFTER CONSULTING WITH MEDTRONIC TECHNICAL SERVICES, THE PHYSICIAN WAS INFORMED OF THE KNOWN ISSUE AND IT WAS RECOMMENDED THE DEVICE BE RE-INTERROGATED LATER IN THE DAY AFTER THE BATTERY VOLTAGE MEASUREMENT HAD UPDATED WITH A VALID READING. THE FALSE ERI ISSUE WAS RESOLVED AND THE DEVICE 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
    464858 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention