BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 1834453 · Received September 15, 2010

    Report

    Report Number
    6000144-2010-04258
    Event Type
    Death
    Date Received
    September 15, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/14/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY IS NORMALLY SUBMITTED VIA A (B)(4) MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(6)2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE OR FOR BOWEL RESECTION, AN ECG MONITOR CAPTURED SEVERAL BEATS OF WIDE COMPLEX TACHYCARDIA UNDETECTED BY THE DEVICE AND REQUIRING EXTERNAL RESCUE. "DEVICE DID NOT DETECT, PROBABLY BECAUSE RATE WAS BELOW PROGRAMMED ZONE." EARLIER IN DAY, DEVICE REPORTED TWO EPISODES OF T-WAVE OVERSENSING RESULTING IN DETECTION AND INAPPROPRIATE SHOCK. PHYSICIAN STATED OVERSENSING WAS NOT SURPRISING DUE TO PATIENT'S SEVERE ELECTROLYTE IMBALANCE. ALSO REPORTED UNDERSENSED R-WAVES. IT WAS LATER NOTED BY MANUFACTURER'S REPRESENTATIVE THAT THE PATIENT EXPIRED "WITH NO APPARENT COMPLICATIONS FROM THE DEVICE." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PATIENT WAS IN OR FOR BOWEL RESECTION, ECG MONITOR CAPTURED SEVERAL BEATS OF WIDE COMPLEX TACHYCARDIA UNDETECTED BY DEVICE AND REQUIRING EXTERNAL RESCUE. MONITOR STRIP SHOWED ARRHYTHMIA DID NOT MEET REQUIRED DETECTION ALGORITHM AS WAS BELOW PROGRAMMED RATE. PATIENT HAD BEEN "EXTERNALLY SHOCKED INAPPROPRIATELY FOR RHYTHM THAT WAS INAPPROPRIATELY SEEN AS VT." EARLIER IN DAY, DEVICE REPORTED TWO EPISODES OF T-WAVE OVERSENSING RESULTING IN DETECTION AND INAPPROPRIATE SHOCK. PHYSICIAN STATED OVERSENSING WAS NOT SURPRISING DUE TO PATIENT'S SEVERE ELECTROLYTE IMBALANCE. ALSO REPORTED UNDERSENSED R-WAVES. LATER NOTED BY MANUFACTURER'S REPRESENTATIVE THAT PATIENT EXPIRED "WITH NO APPARENT COMPLICATIONS FROM THE DEVICE. PER THE PHYSICIAN, CAUSE OF DEATH WAS CARDIOMYOPATHY AND THERE WAS NO CONCERN REGARDING DEVICE PERFORMANCE. PATIENT WAS NOT PACEMAKER DEPENDENT AND LAST DEVICE CHECK (B)(6) 2010 SHOWED NORMAL DEVICE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR ASKU LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H| L| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD