BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRINSIC

    MDR report key: 2032076 · Received March 28, 2011

    Report

    Report Number
    6000144-2011-01092
    Event Type
    Death
    Date Received
    March 28, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING - VENTRICULAR NST<=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 09:54:27 AND 10:58:36. VF<=210 MS ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 07:38:17 AND 11:05:28. INTERFERENCE/NOISE - VENTRICULAR SHORT INTERVAL COUNT V-SIC=863.5 COUNTS AVG/DAY, IN 0.61 DAY, ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 03:16:48 AND 18:00:41. BATTERY VOLTAGE - PROGRAMMER SHOWS ERI=2.62V ON (B)(6) 2011, DEVICE ERI<=2.62 V. SAVE TO DISK, LAST BATTERY MEASUREMENT=2.58 VOLT ON (B)(6) 2011 18:00:41. CHARGE TIME - PATIENT ALERT FOR CHARGE CIRCUIT TIMEOUT ON (B)(6) 2011 11:10:27. PATIENT ALERT FOR LONG CHARGE TIME ">30" ON (B)(6) 2011 11:10:27. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2011. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6) 2011 . INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PATIENT HAD MULTIPLE EPISODES" AND OF THE EPISODES RECORDED BY THE DEVICE, ALL APPEARED TO BE APPROPRIATE. IT WAS ALSO REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD CHARGE CIRCUIT TIME OUT. ICD REPLACEMENT RECOMMENDED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PATIENT HAD MULTIPLE EPISODES" AND OF THE EPISODES RECORDED BY THE DEVICE, ALL APPEARED TO BE APPROPRIATE. IT WAS ALSO REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD CHARGE CIRCUIT TIME OUT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED THE PATIENT HAD BEEN IN A VENTRICULAR TACHYCARDIA STORM FOR UPWARDS OF TWO DAYS. AS A RESULT, HE RECEIVED MULTIPLE, APPROPRIATE THERAPIES. WAS SCHEDULED FOR HEART TRANSPLANT, BUT DIED BEFORE COULD BE DONE. ALSO REPORTED PATIENT WAS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death