BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 13226170 · Received January 11, 2022

    Report

    Report Number
    3004209178-2022-00465
    Event Type
    Injury
    Date Received
    January 11, 2022
    Report Date
    February 10, 2022
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377745, SERIAL/LOT #: (B)(4), UBD: 03-OCT-2010, UDI#: (B)(4); PRODUCT ID: 3708140, SERIAL/LOT #: (B)(4), UBD: 02-OCT-2010, UDI#: (B)(4); PRODUCT ID: 3708240, SERIAL/LOT #: (B)(4), UBD: 01-MAY-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 377745 LOT# V013107. IMPLANTED: (B)(6) 2006. EXPLANTED: (B)(6) 2015. PRODUCT TYPE LEAD PRODUCT ID 3708140 LOT# SERIAL# (B)(6). IMPLANTED: (B)(6) 2006. EXPLANTED: (B)(6) 2015, PRODUCT TYPE EXTENSION PRODUCT ID 3708240 LOT# SERIAL # (B)(6), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015. PRODUCT TYPE EXTENSION 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN, FAILED BACK SURGERY SYNDROME, RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYN, AND RADICULOPATHY. IT WAS REPORTED THAT THE PATIENT SAID THEY HAD AN "EXTENSION CORD" BETWEEN THE LEADS BECAUSE THE LEADS COULDN'T FIT DOWN TO WHERE THE IMPLANT WAS WHEN THEY FIRST GOT THE IMPLANT PUT IN AND THE CORD BURNT UP INSIDE THEM. THE PATIENT SAID THIS FRIED THE LEADS AND THEIR INTERNAL BATTERY SO THEY HAD TO HAVE THE ENTIRE UNIT REPLACED IN 2013 OR 2014.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. PATIENT REPORTED CAUSE WAS UNKNOWN. PATIENT REPORTED IT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559981 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention "SEE H10...."