BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3051541 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04862
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED, AND THERE WERE 21-VENTRICULAR NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 210 MS ON (B)(6) 2013. FOUR VENTRICULAR FIBRILLATION (VF) EPISODES OF LESS THAN OR EQUAL TO 200 MS AVERAGE V-CYCLE OCCURRED ON (B)(6) 2013. DAILY PACE IMPEDANCE TREND DATA SHOWS AN INCREASE FOR VENTRICULAR PACE OF 432 TO 1184 OHMS PEAK BETWEEN (B)(6) 2013. VENTRICULAR SHORT INTERVAL COUNT V-SIC OF 2932 COUNTS OCCURRED IN 1.86 DAYS BETWEEN 22-(B)(6) 2013.

    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

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

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT HAD A SEVERE FALL SEVEN MONTHS PRIOR AND FRACTURED THEIR ARMS AND RIB CAGE. NO PROBLEMS HAD BEEN SEEN ON SUBSEQUENT FOLLOW-UP CHECKS OF THE DEVICE. IT WAS REPORTED THAT APPROX. 6 MONTH AFTER A SEVERE FALL FRACTURING ARMS AND RIB CASE, A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEVERAL SHOCKS. THE PHYSICIAN OBSERVED 12 INAPPROPRIATE SHOCKS FROM EGM RECORDS. VV INTERNAL RECORD WAS SEEN 2932 AND LIA WAS NOT LOADED. AT THE LAST PERIOD THE LEAD IMPEDANCE INCREASES TO AROUND 600-700 OHMS. (NORMALLY RV PACING LEAD MEASURES 400-500 OHMS) PHYSICIAN OBSERVED NOISES AND TURNED-OFF ALL DETECTIONS. PATIENT IS HOSPITALIZED FOR A LEAD REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SEVERAL INAPPROPRIATE SHOCKS OBSERVED BY EMERGENCY ROOM PHYSICIAN AND ON INTERROGATION THE RIGHT VENTRICULAR (RV) LEAD WAS SEEN TO HAVE OVERSENSING AND NOISE. A RISE IN THE IMPEDANCE WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149797 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| L| R 7232 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)