BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA 300 SR

    MDR report key: 1652111 · Received April 7, 2010

    Report

    Report Number
    6000144-2010-01492
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    March 30, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVENT DESCRIPTION: AS THE POST-MORTEM INTERROGATION WAS PERFORMED AFTER THE PATIENT'S ARRIVAL AT THE MORGUE, MEDTRONIC TECHNICAL SERVICES ADVISED THE BATTERY VOLTAGE MAY BE LOWER THAN EXPECTED DUE TO THE COLD TEMPERATURES. THE PHYSICIAN ALSO INDICATED HIS REVIEW OF THE DEVICE MEMORY REVEALED THIRD-DEGREE AV BLOCK AND SUSPECTED A POTENTIAL PACEMAKER FAILURE. THE CAUSE OF DEATH WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED. FINALLY, THE PHYSICIAN INDICATED THE DEVICE WOULD BE REMOVED AND RETURNED PRIOR TO BURIAL; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. AS THE POST-MORTEM INTERROGATION WAS PERFORMED AFTER THE PATIENT'S ARRIVAL AT THE MORGUE, MEDTRONIC TECHNICAL SERVICES ADVISED THE BATTERY VOLTAGE MAY BE LOWER THAN EXPECTED DUE TO THE COLD TEMPERATURES. THE PHYSICIAN ALSO INDICATED HIS REVIEW OF THE DEVICE MEMORY REVEALED THIRD-DEGREE AV BLOCK AND SUSPECTED A POTENTIAL PACEMAKER FAILURE. THE CAUSE OF DEATH WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED. EVALUATION SUMMARY - (B) (4) NO ANOMALIES FOUND. ANALYSIS OF THE DEVICE FOUND THE DEVICE WAS FUNCTIONAL AT EXPLANT AND THE WIRE LIFT WAS POST EXPLANT.

    Description of Event or Problem · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT, A (B) (6) CHILD, WAS DISCOVERED AT 1:15 A.M. ON (B) (6) 2010, NOT BREATHING. AN AMBULANCE WAS IMMEDIATELY CALLED AND DISPATCHED TO THE CHILD'S HOUSE. UPON ARRIVAL, THE EMERGENCY MEDICAL TECHNICIAN (EMT) FOUND THE PATIENT TO BE IN VENTRICULAR FIBRILLATION. EXTERNAL RESCUE WAS ATTEMPTED WHILE THE PATIENT WAS EN ROUTE TO AND AT THE HOSPITAL. HOSPITAL PERSONNEL NOTED PACING SPIKES FROM THE DEVICE ON AN ECG PERFORMED UPON ARRIVAL. IN ADDITION, THE DEVICE WAS PACING AT 65 BEATS PER MINUTE (BPM). THE DEVICE HAD REPORTEDLY BEEN INTERROGATED ON (B) (6) 2010. AT THIS TIME, INTERROGATION SHOWED A BATTERY VOLTAGE OF 2.78 V AND AN IMPEDANCE OF 1,142 OHMS. A POST-MORTEM INTERROGATION OF THE DEVICE REVEALED A BATTERY VOLTAGE OF 2.62 V AND AN IMPEDANCE OF 12,215 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death| R