BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3800787 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08760
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    March 14, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE X-RAY WAS TAKEN ON (B)(6) 2014 AND WAS VIEWED BY THE IMPLANTING PHYSICIAN ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AT THE TIME OF THE REPORT. THE DATE OF THE X-RAY WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD MIGRATION, SO THE LEAD REVISION AND REPROGRAMMING OCCURRED. THE PADDLE LEAD WAS REMOVED AND TWO DIFFERENT LEADS WERE IMPLANTED TO REPLACE IT. ONE LEAD WAS IMPLANTED RETROGRADE TO CAPTURE LOWER EXTREMITY PAIN AND THE OTHER WAS PLACED HIGHER TO CAPTURE LOW BACK PAIN. DIAGNOSTIC TESTING OR TROUBLESHOOTING PERFORMED INCLUDED IMPEDANCE TESTING, X-RAYS, AND REPROGRAMMING. THE ISSUE WAS RESOLVED, BUT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT EXPERIENCED STOMACH, RIB AND GROIN STIMULATION BUT INADEQUATE COVERAGE IN HIS PRIMARY PAIN AREAS. AN X-RAY WAS TAKEN WITHIN A MONTH POST-OP WHICH INDICATED THAT THE PADDLE LEAD HAD MIGRATED LATERALLY FROM THE INITIAL INTRA-OP POSITION ELICITING STOMACH AND RIB STIMULATION, AND LITTLE STIMULATION IN THE FEET WHICH WAS ONE OF HIS PRIMARY PAIN AREAS. MULTIPLE REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, ADEQUATE COVERAGE WAS NOT ABLE TO BE SUSTAINED. THE PATIENT WAS SCHEDULED FOR LEAD REVISION ON (B)(6) 2014. PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT WERE LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED TO BE SEEN ON (B)(6) 2014, ONE DAY AFTER THE REPORT, FOR PROGRAMMING OF ADAPTIVE STIMULATION. THE PATIENT WAS OTHERWISE DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278925 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