BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 3991806 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14225
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIGGERED ON (B)(4) 2014. THE DEVICE WAS INTERROGATED ON (B)(4) 2014 BY PROGRAMMER. SAVE-TO-DISK FILE FROM (B)(4) 2014 SHOWS THE FALSE ERI HAD BEEN CLEARED BY THE PROGRAMMER WITH UPDATED SOFTWARE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 407652 LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI) AND A REPLACEMENT WAS SCHEDULED. HOWEVER WHEN THE IPG WAS PRE-OPERATIVELY INTERROGATED, IT INDICATED SEVERAL YEARS OF LONGEVITY WERE LEFT. 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
    467872 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention 407658 LEAD