BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3973228 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02153
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 1, 2012
    Report Date
    April 13, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-40, LOT# 0205673042, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT IS NOW REPORTABLE FOR SERIOUS INJURY. PRODUCT ID: 3389-40, LOT# 0205673042, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 7426, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3389-40, LOT# 602484883, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN (B)(6) 2012. DURING A REGULAR VISIT WITH THE HCP, THE DOCTOR FOUND THE LEAD IMPEDANCE WAS HIGHER THAN NORMAL. AN X-RAY WAS PERFORMED WHICH SHOWED THE LEAD WAS BROKEN. THE DOCTOR SUGGESTED REPLACING THE LEAD. IT WAS NOTED THAT THE PATIENT WAS OK OVERALL. FOLLOW UP INFORMATION INDICATED THE ORIGINAL IMPLANT SURGERY IN 2012 WAS SUCCESSFUL AND THE PATIENT HAD BETTER SYMPTOMS AFTER THE SURGERY. IT WAS UNKNOWN IF THE PATIENT HAD ANY SYMPTOMS PRIOR TO THE DOCTOR DISCOVERING THE BROKEN LEAD. IT WAS ALSO UNKNOWN WHAT CAUSED THE LEAD BREAK. IT WAS NOTED THAT THE PATIENT WAS ¿IN OBSERVATION.¿ FURTHER INFORMATION INDICATED THE LEAD WAS NOT EXPLANTED. IT WAS STATED THAT THE PATIENT ¿IS FINE NOW.¿ IT WAS UNKNOWN IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR INTRACTABLE EPILEPSY. IT WAS REPORTED THAT A MEDICAL EXAMINATION TOOK PLACE IN 2014 IN WHICH IT WAS FOUND THAT TWO LEADS WERE BROKEN. AT THAT TIME, A REPLACEMENT WAS SUGGESTED BUT THE PATIENT DECIDED TO TURN OFF THE STIMULATOR INSTEAD. THE PATIENT RETURNED TO THE HOSPITAL IN (B)(6) 2018 WHICH SHOWED THAT THE IMPLANT ON BOTH SIDES WERE IN A STATE OF DEPLETION. A SURGERY TO REPLACE THE LEADS AND STIMULATORS IS SCHEDULED FOR (B)(6). THE PATIENT WAS DISSATISFIED AS THEY WERE ONLY ABLE TO USE THE BATTERY FOR TWO YEARS. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450504 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Required Intervention