BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7269858 · Received February 14, 2018

    Report

    Report Number
    3004209178-2018-03278
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    February 6, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# LA4613, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-40, SERIAL (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998. LOT#: LA4613 , IMPLANTED: (B)(6) 2002 EXPLANTED: PRODUCT TYPE: LEAD. PRODUCT ID: 37082-40, SERIAL# :(B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED DURING PATIENT BATTERY REPLACEMENT THE OLD BATTERY POCKET WAS OPEN AND THE EXTENSION THAT WAS CONNECTED TO THE LEAD WAS DISCONNECTED FROM INS. UPON ATTEMPTING TO INSERT THE LEAD INTO THE NEW INS, THE LEAD APPEARED TO HAVE CORROSION AND IT WOULD NOT FULLY GO INTO EITHER OF THE SLOTS. THE SET SCREW WAS LOOSENED AND IT STILL WOULD NOT GO IN. EVENTUALLY THE HEALTH CARE PROFESSIONAL (HCP) DECIDED TO TRY TO REPLACE THE EXTENSION. AN INTERMEDIATE INCISION WAS DONE WHERE THE EXTENSION CONNECTED TO THE LEAD. WHEN THE BOOT WAS SLID OFF, THE CASING OR INSULATION OF THE LEAD APPEARED TO PULL OR BREAK AND THE WIRE SEEMED SOMEWHAT FRAYED. THE LEAD WAS THEN TESTED WITH A TEST TABLE. THE IMPEDANCES ONLY SHOWED ELECTRODE 0 OUT OF RANGE. THE HCP ELECTED TO TRY TO CONNECT THE LEAD AND PROCEED, BUT THE LEAD APPEARED TOO DAMAGED AND THE HCP COULD NOT REINSERT IT. THE PATIENT WAS NOT CONSENTED FOR LEAD REVISION SO HE ELECTED TO REMOVE THE EXTENSIONS AND LEAVE THE LEAD IN PLACE AS DEACTIVATED. THE EXTENSION WAS EXPLANTED IN (B)(6) 2018. THE LEAD WAS NOT REPLACED BUT WILL BE REPLACED IN THE FUTURE. THE OTHER EXTENSION THAT WAS CONNECTED TO THE 2 SQ QUAD LEADS WAS INSERTED INTO 0-7 AND THAT CONNECTION WAS FINE. EVERYTHING CLOSED. PATIENT HAS THE SAME QUALITY COVERAGE WITH THESQ LEADS AS BEFORE. HEALTH CARE PROFESSIONAL (HCP) WILL DISCUSS REPLACEMENT OF LEAD IN THE FUTURE. NO THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. NO HCP HAS NO FURTHER INFORMATION FOR MANUFACTURE. PATIENT IS ALIVE WITH NO INJURY. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. IT WAS REPORTED THAT THE LEAD REVISION WAS SCHEDULED FOR (B)(6) 2018. THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE EXTENSION BEING UNABLE TO PLUG INTO THE BATTERY (BESIDES CORROSION). NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE LEAD APPEARED TO BE CORRODED, THE EXACT REASON WAS UNKNOWN. THE LEAD REPLACEMENT HAS NOT BEEN SCHEDULED. THE LEAD IS IN PLACE, BUT NOT ATTACHED. THE EXTENSION WAS TAKEN OUT BECAUSE THEY COULD NOT PLUG IN IT IN THE BATTERY SO IT WAS DISPOSED OF. THE LEAD WAS NOT EXPLANTED DURING CASE BECAUSE THEY DID NOT HAVE CONSENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114359 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention