BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 10135601 · Received June 9, 2020

    Report

    Report Number
    3004209178-2020-10000
    Event Type
    Injury
    Date Received
    June 9, 2020
    Report Date
    August 5, 2020
    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
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID: 3708140, LOT# SERIAL#: (B)(6), IMPLANTED: ON (B)(6) 2006, EXPLANTED: ON (B)(6) 2020, PRODUCT TYPE: EXTENSION, PRODUCT ID: 3708140, LOT# SERIAL#: (B)(6), IMPLANTED: ON (B)(6) 2006, EXPLANTED: ON (B)(6) 2020, PRODUCT TYPE: EXTENSION, PRODUCT ID: 377645, LOT# V012854, IMPLANTED: ON (B)(6) 2006, EXPLANTED: ON (B)(6) 2020, PRODUCT TYPE: LEAD, PRODUCT ID: 377645, LOT#: V012709, IMPLANTED: ON (B)(6) 2006, EXPLANTED: ON (B)(6) 2020, PRODUCT TYPE: LEAD, PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY, PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY, H3: ANALYSIS OF THE INS (NMD712778H) FOUND THAT IT HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. ANALYSIS OF THE EXTENSION (NJB006585V) FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION (NJB007669V) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (V012854) FOUND THE STIM LEAD BODY CONDUCTOR WAS BROKEN WITHIN 10 CM OF CONNECTOR AREA AND CONDUCTOR 3 WAS BROKE AT 3.7 CM FROM THE PROXIMAL END. ANALYSIS OF THE LEAD (V012709) FOUND THAT A CONDUCTOR WAS BROKEN AT THE TITAN ANCHOR SITE AND THE PROXIMAL END CONDUCTOR WAS BROKEN. CONDUCTORS 1 AND 3 WERE BROKEN 8.9 CM FROM THE DISTAL END OF THE DISTAL SEGMENT AND CONDUCTOR 5 WAS BROKEN AT 1.7 CM FROM THE PROXIMAL END OF THE PROXIMAL SEGMENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708140, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION; PRODUCT ID: 377645, LOT#: V012854, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD; PRODUCT ID: 377645, LOT#: V012709, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708140, SERIAL/LOT#: (B)(4), UBD: 28-JUL-2010, UDI#: (B)(4); PRODUCT ID: 3708140, SERIAL/LOT#: (B)(4), UBD: 06-SEP-2010, UDI#: (B)(4); PRODUCT ID: 377645, SERIAL/LOT#: (B)(4), UBD: 27-SEP-2010, UDI#: (B)(4); PRODUCT ID: 377645, SERIAL/LOT#: (B)(4), UBD: 25-SEP-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER AND A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE DEVICE WAS GIVING THE PATIENT INTERMITTENT SHOCKING. THE PATIENT HAD A FALL WHERE THEY FELL FLAT ON THEIR BACK AND THEY BELIEVED THAT WAS WHERE THE PROBLEM BEGAN. TROUBLESHOOTING WAS PERFORMED, IMPEDANCES WERE CHECKED AND REPROGRAMMING ATTEMPTED. IT WAS REPORTED THERE WAS SURGICAL REVISION. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598415 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention