BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7844256 · Received September 4, 2018

    Report

    Report Number
    3004209178-2018-19855
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 30, 2018
    Report Date
    October 1, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 977C165 LOT# SERIAL# (B)(4) IMPLANTED: 2018-(B)(6) EXPLANTED: PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: 977C165, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977C165, SERIAL/LOT #: (B)(4), UBD: 11-APR-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 977C165 SERIAL(B)(4) IMPLANTED: (B)(6)2018 PRODUCT TYPE LEAD MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT¿S INCISIONS HAD IMPROVED WITH ANTIBIOTIC TREATMENT AND THEY WOULD SEE HIM BACK NEXT WEEK. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CHRONIC LOW BACK PAIN, LUMBAR RADICULOPATHY AND SPINAL PAIN VIA A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT PRESENTED AT THE NEUROSURGEON¿S OFFICE FOR A POST-OPERATIVE APPOINTMENT AND STAPLE REMOVAL. THE REP REPORTED THAT UPON REMOVAL OF THE DRESSING, THE HCP NOTED REDNESS AND HEAT AT THE BATTERY INCISION SITE. THE LEAD SITE WAS LESS RED AND THE HCP BEGAN TO REMOVE THE STAPES. THE REP REPORTED THAT AT THIS POINT, THE SITE BEGAN TO OOZE FLUID AND HAD AN ODOR. THE REP REPORTED THAT THE HCP OPTED TO LEAVE THE STAPLES INTACT AND ORDERED 500MG CEPHALEXIN 4 TIMES A DAY ALONG WITH CIPROFLOXACIN 500MG 2 TIMES A DAY. THE PATIENT WAS TO RETURN IN ONE WEEK FOR EVALUATION OF WOUNDS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE REDNESS, HEAT AT THE BATTERY SITE, OOZING FLUID AND ODOR WAS UNKNOWN. THE REP REPORTED THAT THEY HADN¿T RECEIVED ANY UPDATES ON THE PATIENT AS THE FOLLOW UP APPOINTMENT WAS SCHEDULED FOR (B)(6)2018. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685520 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention