BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3781334 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08273
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-0500-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_SLEEVE/ANCHOR, SERIAL # UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED THE NEU_SLEEVE/ANCHOR TO THE FOLLOWING: PRODUCT ID 3550-39, SERIAL# UNKNOWN, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ANY THERAPEUTIC BENEFIT FROM THE THERAPY BECAUSE THE LEADS HAD MIGRATED AND THE STIMULATION WAS IN THE WRONG LOCATION. IT WAS NOTED THAT THERE WAS A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT INCLUDED LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. IT WAS NOTED THAT PREVIOUS ATTEMPTS TO REVISE THE LEAD HAD FAILED. IT WAS ALSO NOTED THAT WHEN THE PHYSICIAN DISSECTED DOWN TO THE ANCHOR TO REMOVE THE LEADS THEY FOUND THAT THE ANCHOR METALLIC CENTER HAD SEPARATED FROM THE SILICONE SHEATH. IT WAS NOTED THAT THE PHYSICIAN THOUGHT THAT THIS WAS WHY THE LEAD MIGRATED. IT WAS NOTED THAT ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED EXPLANT. THE PRODUCT STATUS OF BOTH LEADS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED-COMPLETE. DIAGNOSTICS OR TROUBLESHOOTING INCLUDED REPROGRAMMING. THE ISSUE WAS NOT RESOLVED. THE CAUSE OF ISSUE WAS NOT DETERMINED. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS LATER REPORTED THAT THE REPORT THE MANUFACTURER REPRESENTATIVE SUBMITTED WAS BASED UPON INFORMATION TOLD TO THEM ANECDOTALLY BY THE PHYSICIAN ON THE DAY OF THE PROCEDURE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS THERE ¿DOING A DIFFERENT CASE¿ WITH ¿HER¿ PRIOR TO THIS ONE. THE MANUFACTURER REPRESENTATIVE NOTED THAT THEY ATTEMPTED TO REPROGRAM THE PATIENT PRIOR TO THE EXPLANT PROCEDURE TO CONFIRM THAT THE STIMULATION COVERAGE WAS NOT IN THE APPROPRIATE LOCATION. THE MANUFACTURER REPRESENTATIVE DID NOT KNOW WHAT TYPES OF TROUBLESHOOTING WERE DONE PRIOR TO THAT DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE EVENT WAS ATTRIBUTED TO THE ANCHOR. IT WAS NOTED THAT THERE WAS A LEAD MIGRATION DUE TO THE BROKEN ANCHOR. IT WAS UNKNOWN IF THE DEVICES WOULD BE RETURNED. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. THE PATIENT OUTCOME WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259036 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention