BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2525T MICRONY II, SR+, PKGD/STER

    MDR report key: 11879381 · Received May 25, 2021

    Report

    Report Number
    2017865-2021-18863
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    June 14, 2021
    Product Code
    LWO
    UDI-DI
    05414734006224
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN ALLEGED THERE WERE NO EPISODES OR RECORDS WHICH COULD HAVE LEAD TO THE SYMPTOMS OF THE PATIENT. THE PHYSICIAN DID NOT ALLEGE THE EVENT WAS DUE TO INAPPROPRIATE PROGRAMMING OF THE PACEMAKER.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2017865-2014-09122. THE PATIENT WAS IMPLANTED WITH A PACEMAKER ON (B)(6) 2012 TO TREAT PALLID BREATH-HOLDING SPELLS WITH ASYSTOLE. FOLLOWING IMPLANT, THE PATIENT IS REPORTED TO HAVE EXPERIENCED SEVERE PAIN AT NIGHT. IT WAS OBSERVED THE DEVICE WAS PREVIOUSLY PROGRAMMED TO "PERMANENT PACING" AT A FOLLOW-UP APPOINTMENT AND WAS REPROGRAMMED TO RESOLVE THE SITUATION. THE PATIENT EXPERIENCED PAINFUL SEIZURES REQUIRING RESUSCITATION. THE PATIENT LOST CONSCIOUSNESS WHILE INTERACTING WITH A MAGNETIC TOY. TO AVOID FURTHER SYNCOPE, MAGNETIZED OBJECTS WERE REMOVED FROM THE PATIENT¿S PROXIMITY. IN (B)(6) 2015, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO EXTREME SYNCOPE. THE PHYSICIANS RECORDED PACEMAKER ACTIVITY DURING THE AMBULANCE RIDE AND THE PATIENT HAD A SOLID HEART RATE. FOLLOWING THE AMBULANCE RIDE, SINUS BRADYCARDIAS WITH DIZZINESS AND VOMITING WITHOUT TRIGGER OCCURRED. HEAVY PHYSICAL EXERTION BY THE PATIENT NOW RESULTS IN VERY HIGH HEART RATES. THE PHYSICIAN REPORTED THAT IT CANNOT BE RULED OUT THAT A STIMULATION CONDUCTION DISORDER MAY OCCUR DUE TO MANY INCORRECT STIMULATIONS. THE EVENT WAS RESOLVED BY REPLACING THE PACEMAKER. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WOULD INAPPROPRIATELY PACE WITHOUT REGARDS TO PROGRAMMING. IT WAS REPORTED THE PHYSICIAN ALLEGED A SOFTWARE ERROR, BUT IT WAS NOT CONFIRMED. IT WAS REPORTED A REVIEW OF THE EVENT BY ABBOTT TECHNICAL SUPPORT INDICATED AN IMPLANT DATE PROGRAMMER ISSUE WHICH WAS RESOLVED IN A SUBSEQUENT SOFTWARE RELEASE. FURTHER INFORMATION INDICATED THE PACEMAKER EXHIBITED A DIAGNOSTIC ANOMALY. FOLLOWING THE DEVICE REPLACEMENT, THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777348 2525T MICRONY II, SR+, PKGD/STER IMPLANTABLE PACEMAKER PULSE GENERATOR LWO 2525T 3669431 05414734006224

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R