BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 3051554 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05955
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED, BUT WE DID REVIEW PERFORMANCE DATA. BATTERY VOLTAGE MEASURES 2.03 VOLTS. BATTERY IMPEDANCE MEASURES 737 OHMS. DEVICE NOT AT ERI (ELECTIVE REPLACEMENT INDICATOR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE INTERROGATION, THE BATTERY VOLTAGE WAS SHOWN TO BE FAR BELOW THE LEVEL AT WHICH THE ELECTIVE REPLACEMENT INDICATOR (ERI) WOULD BE TRIGGERED; HOWEVER, THE BATTERY STATUS WAS NOT SHOWING THAT THE DEVICE HAD REACHED ERI. IT WAS ALSO REPORTED THAT A FALSE BATTERY VOLTAGE READING WAS SEEN AS THE INTERNAL REFERENCE VOLTAGE WAS BEING MEASURED ALONG WITH THE BATTERY VOLTAGE, WHICH IN TURN CAUSES THE REFERENCE VOLTAGE MEASUREMENT TO BE INCORRECT. 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
    152927 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR 5076 IMPLANTABLE PACING LEAD