BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2200592 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01088
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED; HOWEVER, DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT. (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 19:59:51. 15 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2011 23:09:18 AND (B)(6) 2011 02:00:37. 1 - VF=160 MS ON (B)(6) 2010 19:59:51. VENTRICULAR SHORT INTERVAL COUNT V-SIC=18.3 COUNTS AVG/DAY, IN 2.30 DAYS, BETWEEN (B)(6) 2011 02:17:48 AND (B)(6) 2011 09:26:57. LAST BATTERY MEASUREMENT=2.56 VOLT ON (B)(6) 2011 09:16:52, SHOWS DEVICE WAS AT ERI, BATTERY MEASUREMENT WAS LOWER THAN DEVICE RRT (RECOMMENDED REPLACEMENT TIME) <=2.63 V. WEEKLY TREND DATA SHOWS MIN BAT=3.17 VOLTS BETWEEN (B)(6) 2011. EVENT DESCRIPTION CONTINUED: THE RIGHT VENTRICULAR (RV) LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD AND THE UNKNOWN OTHER LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO ALERT TONES SOUNDING. THERE WERE SEVERAL NON-SUSTAINED TACHYCARDIAS (NST) WITH ELECTROMAGNETIC INTERFERENCE (EMI) TYPE WAVEFORMS ON THE ELECTROGRAMS (EGMS). THE BATTERY VOLTAGE HAD SHOWN A DECREASE AT THE END OF THE INTERROGATION SESSION. THERE WAS ALSO ONE VENTRICULAR TACHYCARDIA (VT) DETECTION WHICH TERMINATED PRIOR TO THERAPY. THE FOLLOWING DAY THE DEVICE WOULD NOT INTERROGATE; PATIENT HEARD NO TONES AND IT WAS VERIFIED ON THE EGM THAT THE DEVICE WAS NOT PACING. IT WAS ALSO REPORTED THAT THERE WAS NO DEVICE PACING OUTPUT, PROGRAMMING/TELEMETRY PROBLEM AND SUSPECTED EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. A LAWSUIT ALLEGES THAT THE DEVICE "FAILED WITHOUT NOTICE OR REASON." IT WAS FURTHER REPORTED THAT A CHECK OF THE DEVICE SHOWED A SUDDEN DROP IN BATTERY VOLTAGE AND THAT NOISE WAS NOTED ON BOTH LEADS. DESCRIPTION CONTINUED IN NARRATIVE SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PACING LEAD NVZ MEDTRONIC, INC. LEAD/UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD