BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 7682863 · Received July 12, 2018

    Report

    Report Number
    3004209178-2018-15634
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    July 7, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A290, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A290, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2019, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 977A290 LOT# SERIAL# (B)(4) IMPLANTED: 2016 (B)(6) EXPLANTED: 2018 (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 977A290 LOT# SERIAL# (B)(4) IMPLANTED: 2016 (B)(6) EXPLANTED: 2018 (B)(6) PRODUCT TYPE LEAD PRODUCT ID 977A275 LOT# SERIAL# (B)(4) IMPLANTED: 2016 (B)(6) EXPLANTED: PRODUCT TYPE LEAD. DEVICE CODE DOES NOT APPLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. PATIENT HAS A CRANIAL PERIPHERAL NERVOUS SYSTEM (PNS) LEAD PLACED HORIZONTALLY ABOVE HER RIGHT EAR AND A PNS LEAD PLACED VERTICALLY ON THE RIGHT SIDE OF HER NECK. THE LEAD IN HER NECK IS STILL IMPLANTED AND WITHOUT ISSUE. ON (B)(6) 2018, THE PATIENT CALLED HER HCP TO REPORT THAT HER CRANIAL LEAD PROTRUDED THROUGH HER SKIN ON (B)(6) 2018. STATING THE CONCERN FOR INFECTION, THE HCP DECIDED NOT TO REMOVE THE PROTRUDING LEAD, SO HE TRIMMED THE LEAD AT THE PROTRUSION SITE AND SUTURED IT CLOSED. PATIENT REPORTED NO FALLS, TRAUMA OR INJURIES THAT WOULD HAVE CONTRIBUTED TO THE LEAD PROTRUDING. THE PATIENT SHARED THAT ON SATURDAY, (B)(6) 2018 SHE HAD JUST WOKEN UP, WAS SITTING UP IN BED AND SIMPLY LOOKED DOWN, FELT A ¿POP¿ AND FELT THE LEAD PROTRUDING THROUGH HER SKIN ABOVE HER EAR. BECAUSE IT WAS A SATURDAY AND BECAUSE SHE IS BETWEEN JOBS WITHOUT HEALTH INSURANCE, SHE WAITED UNTIL MONDAY, (B)(6), TO REPORT THE INCIDENT TO HER SURGEON. WITH RESPECT TO THE PATIENT¿S PROGRAMMING, IMPEDANCE TEST RETURNED NORMAL RESULTS ON HER PNS NECK LEAD (LEAD #2). THE REPRESENTATIVE DELETED LEAD #1 FROM HER PROGRAMMING AND REPROGRAMMED LEAD #2, WHICH PROVED TO RETURN HALF OF HER THERAPY. THE HCP PLANS TO REMOVE AND REPLACE AFFECTED LEAD AT A LATER DATE TO BE DETERMINED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT'S LEAD WAS PARTIALLY EXPLANTED ON 2018-(B)(6). THE REMAINING LEAD WAS PULLED TODAY (2018-(B)(6)) AND REPLACED WITH A NEW ONE. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPRESENTATIVE REPORTED LEAD WAS DISCARDED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526155 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention