BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4251440 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21611
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3986A70, LOT# N374590, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A45, LOT# N417400, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) CUT THE LEADS. THE REMAINDER TAILS OF THE LEADS AND EXTENSIONS REMAIN. THE PATIENT WOULD REVISE IN A COUPLE OF WEEKS. THE EXPLANTED LEADS WERE SENT TO THE LAB FOR CULTURE. THERE WAS NO ALLEGED PRODUCT ISSUE. IMPEDANCE TESTING WAS DONE. PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY, AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT DID NOT PRESENT WITH SIGNS OF INFECTION, BUT DID PRESENT WITH A PORTION OF THE LEAD STICKING OUT FROM THE SKIN. THE PATIENT WAS RECOVERING WITHOUT SEQUELA OR INFECTION. PROPHYLACTIC ANTIBIOTICS WERE PRESCRIBED. THE HCP PLANNED TO BRING THE PATIENT BACK TO THE OPERATING ROOM IN A MONTH OR SO TO REPLACE THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736513 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention