BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990858 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08452
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THIS DATA INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). IT WAS NOTED THAT THERE WAS 284 OF 376 LIFETIME V-SIC RECORDED BEGINNING 23 JUN 2014. ALSO, THERE WAS 1 VF, 1 NST AND 1 "LFP" EVENTS OF <(><<)> 220 MS V-V CYCLE RECORDEDBETWEEN 02 AND 30 JUN 2014.

    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: 429688 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TO WENT TO THE DEVICE CLINIC FOR A ROUTINE FOLLOW UP VISIT. UPON DEVICE INTERROGATION, VS (VENTRICULAR SENSE) MARKERS WERE NOTED AT THE TAIL END OF THE P WAVES. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE DEVICE IS FLIPPED UPSIDE DOWN FROM ITS IMPLANTED POSITION, AND THE LEADS ARE PULLED OUT OF POSITION. THE ELECTRODE TIPS OF THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD WERE DISLODGED INTO THE RIGHT ATRIUM, ALL SLACK WAS COMPLETELY TAKEN UP. THE LEAD BODIES HAD BEEN PULLED BACK INTO THE DEVICE POCKET. THE PHYSICIAN STATED THAT HE SUSPECTS TWIDDLER'S SYNDROME, AND ADDRESSED THIS WITH THE PATIENT. THE PATIENT STATED THAT THEY HAD "BEEN POKING THE WIRES DOWN UNDER THE SKIN" BECAUSE THEY "CAN FEEL THEM", BUT DENIES MANIPULATING THE DEVICE OR MOVING THE WIRES. THE PATIENT WAS THEN SCHEDULED FOR LEAD REVISIONS. AT THE LEAD REVISION PROCEDURE, IT WAS FOUND THAT THE LEADS WERE TWISTED UP IN THE POCKET AND THE DEVICE HAD BEEN FLIPPED UPSIDE DOWN AND BACKWARDS, THROUGH THE LOOPS OF THE LEADS. THE DEVICE WAS REMOVED FROM THE POCKET, WRAPPED IN A STERILE SURGICAL TOWEL AND SET ASIDE ON THE STERILE TABLE. THE RV LEAD WAS RE-POSITIONED TO THE RV APEX, INSTEAD OF THE ORIGINAL RV SEPTAL POSITION, AND REMAINS IN USE. THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD AS IT WAS EXTREMELY DEFORMED FROM BEING WOUND TIGHTLY AROUND THE OTHER LEADS. THE DEVICE WAS RE-IMPLANTED 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
    470846 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R DTBA1D4 ICD