BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1771555 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13232
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    January 29, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THE EVENT WILL BE UPDATED ONCE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT'S SYSTEM WAS EXPLANTED ONE MONTH LATER.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT ADVOCATE STATED THE PATIENT HAS BEEN HOSPITALIZED TWICE DUE TO BUILD UP OF FLUID IN THE LUNGS, LACK OF ENERGY AND UNCONTROLLABLE HIGH BLOOD PRESSURE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) CONTACTED THE PHYSICIAN WHO STATED THAT THERE WAS NO CONCERN OVER PNEUMOTHORAX. HOWEVER, AT THE FOLLOW-UP VISIT THEY DID FIND THAT THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE. THE RA LEAD WAS SUCCESSFULLY REPOSITIONED AND THE PATIENT WAS REPORTED AS DOING WELL. FOUR MONTHS LATER, THE PATIENT ADVOCATE CONTACTED TECHNICAL SERVICES AGAIN AND STATED THAT THE PATIENT WAS ENROLLED IN A SLEEP STUDY WHERE HER HEART RATE WENT TO 29 BPM. THE ADVOCATE MENTIONED THAT A NON-SPECIFIED LEAD WAS FOUND TO HAVE BEEN OFF AND ONCE IT WAS TURNED BACK ON, THE PATIENT'S HEART RATE RETURNED TO NORMAL. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT ADVOCATE WAS REFERRING TO THE NON-BOSTON SCIENTIFIC RA OR NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD. THE ADVOCATE CONTINUED TO RELATE HER CONCERN OVER THE PATIENT'S FLUID BUILD UP AND THE STEROID COLLARS ON THE NON-BOSTON SCIENTIFIC LEADS. ACCORDING TO THE ADVOCATE, THE PATIENT HAS A STEROID ALLERGY. THE SR CONTACTED THE CLINIC TO DISCUSS THE PATIENT ADVOCATE'S NEW ALLEGATIONS AND SPENT SEVERAL HOURS GOING THROUGH THE PATIENT'S MEDICAL CHART. IT WAS NOTED THAT THE SLEEP STUDY, WHERE A LOW HEART RATE OF 29 BPM DID OCCUR, HAPPENED PRIOR TO THE RA LEAD REVISION AND THERE WAS NO MENTION OF CONCERN OVER A LEAD BEING TURNED OFF. THE CHART ALSO NOTED THAT THE PATIENT HAS DOCUMENTED CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE SR STATED THAT THE PHYSICIAN IS CONSIDERING EXPLANTING THE SYSTEM DUE TO THE FAMILY'S CONCERNS.

    Description of Event or Problem · 1

    ONE AND A HALF MONTHS POST EXPLANT, THE PATIENT'S DAUGHTER RELATED THAT AFTER HER MOTHER'S PACEMAKER AND LEADS WERE REMOVED, HER CONDITION VASTLY IMPROVED. ACCORDING TO THE PATIENT'S DAUGHTER, HER MOTHER HAD A SEVERE STEROID ALLERGY THAT WAS DOCUMENTED ON HER CHART, BUT THE DOCTORS DID NOT THINK THE AMOUNT OF STEROID IN THE NON-BOSTON SCIENTIFIC LEADS WOULD HAVE AFFECTED HER THIS WAY. SINCE THE EXPLANT OF THE PACEMAKER SYSTEM, THE PATIENT'S HEART RHYTHMS ARE BACK TO NORMAL AND SHE IS NO LONGER EXPERIENCING HIGH BLOOD PRESSURE OR FLUID RETENTION. THE PATIENT'S DAUGHTER ALSO STATED THAT SHE BELIEVES THAT HER MOTHER'S SYMPTOMS WERE ALL A RESULT OF THE STEROIDS ON THE NON-BOSTON SCIENTIFIC LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 5076| S403