BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STABILITY QUAD MRI SURESCAN

    MDR report key: 14306906 · Received May 6, 2022

    Report

    Report Number
    2649622-2022-08587
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 7, 2026
    Manufacturer
    MPRI
    Product Code
    OJX
    UDI-DI
    00643169860421
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ADDITIONAL INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. REFERENCED ARTICLE: FOUR DEVICES, ONE SOLUTION: GOLD-COATED CARDIAC RESYNCHRONIZATION THERAPY WITH A DEFIBRILLATOR IN A PATIENT WITH TITANIUM HYPERSENSITIVITY. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2025. 68:1797¿1799. DOI: 10.1007/S10840-025-02154-0 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED VIA JOURNAL LITERATURE THAT THE PATIENT HAD PERSISTENT WOUND COMPLICATIONS, CHRONIC DRAINAGE, AND GRAM-POSITIVE BACTEREMIA. DUE TO THE HYPERSENSITIVITY, A GOLD-PLATED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION. IT WAS SUSPECTED THAT THE INFECTION WAS CAUSED BY AN ALLERGIC REACTION TO TITANIUM CASING PRESENT IN THE SYSTEM. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170679 ATTAIN STABILITY QUAD MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 479888 00643169860421

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R 407652 LEAD, DTPA2Q1 CRT-D, 694765 LEAD