BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5404512 · Received February 2, 2016

    Report

    Report Number
    3004209178-2016-01360
    Event Type
    Injury
    Date Received
    February 2, 2016
    Report Date
    May 26, 2016
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 97702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3888-28, LOT# R211691, IMPLANTED: (B)(6) 1992, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA THE MANUFACTURER REPRESENTATIVE (REP) THAT THERE WERE HIGH IMPEDANCES ON THE RIGHT LEAD ON CONTACTS 0 AND 3. THEY WERE GREATER THAN 10000 OHMS. THE PATIENT HAD BEEN UNABLE TO FEEL ANY STIMULATION, EVEN WHEN USING GOOD CONTACTS 1 AND 2. REPROGRAMMING WAS PERFORMED. IT WAS NOTED THAT THE PATIENT HAD LOST THEIR PROGRAMMER AND WAS THEN UNABLE TO TURN STIMULATION ON. IT WAS FURTHER NOTED THAT THE PATIENT HAD 2 PERIPHERAL NERVE STIMULATORS, EACH WITH 1 LEAD AND 1 IMPLANTABLE PULSE GENERATOR (IPG). THE SYSTEM ON THE OUTSIDE OF THE RIGHT LEG WAS THE ONE WITH THE ISSUES. THERE WAS NO WAY TO KNOW WHICH LEAD IT WAS. THE LEAD HAD BEEN IMPLANTED SINCE THE EARLY 90S AND THE IPG WAS REPLACED IN (B)(6) 2015 DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT WAS UNAWARE OF ANY FALLS OR TRAUMA TO THE LEAD OR THE IPG AREA. THE IMPEDANCE RESULTS WERE REPORTED TO THE NURSE WHO WAS GOING TO FOLLOW-UP WITH THE MANAGING DOCTOR TO DETERMINE THE NEXT STEPS. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE WITH NO INJURY, AND NO SURGICAL INTERVENTION HAD OCCURRED AT THE TIME OF THIS REPORT. IT WAS UNKNOWN IF ONE HAD BEEN PLANNED. THE PATIENT WAS GOING TO BE BACK ON (B)(6) 2016. THE REP WAS GOING TO FOLLOW UP WITH THE MANAGING DOCTOR AT THAT TIME. RELEVANT MEDICAL HISTORY INCLUDED NON-MALIGNANT PAIN. NO FOLLOW-UP WAS REQUIRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD A LEAD REVISION ON (B)(6) 2016. THE HEALTHCARE PROFESSIONAL DID NOT WANT TO REMOVE THE PERIPHERAL LEAD WITH HIGH IMPEDANCE AS IT WAS PLACED DIRECTLY ON THE NERVE. INSTEAD, TWO NEW EPIDURAL LEADS WERE PLACED AT T10/11 WITH A NEW IMPLANTABLE NEUROSTIMULATOR (INS). A FOUR-ELECTRODE LEAD, A POCKET ADAPTOR, AN EXTENSION, AND AN INS FROM THE EXISTING THORACIC EPIDURAL SYSTEM WERE EXPLANTED. IT WAS NOTED THAT EXPLANTED COMPONENTS WERE SENT TO PATHOLOGY. THE MANUFACTURER REPRESENTATIVE DID NOT KNOW THE PATIENT'S CONDITION AT THAT TIME AS THE PATIENT DID NOT WISH FOR A NEW SYSTEM TO BE ACTIVATED AFTER THE SURGERY. THE PATIENT WAS SCHEDULED FOR FOLLOW-UP AT THE CLINIC ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64010 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention