BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3503587 · Received December 6, 2013

    Report

    Report Number
    3007566237-2013-03952
    Event Type
    Injury
    Date Received
    December 6, 2013
    Report Date
    November 20, 2013
    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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V006339, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXTENSION FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V006339, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. MANUFACTURER¿S REPORT NUMBER WAS UPDATED TO 3004209178.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A REPLACEMENT WAS BEING DONE THE FIRST INTRAOPERATIVE IMPEDANCE TEST SHOWED ABNORMAL VALUES; HOWEVER, WHEN THEY DISCONNECTED AND DRIED CONNECTIONS THE SUBSEQUENT IMPEDANCE TEST WAS NORMAL. IT WAS NOTED AT THE FIRST REPROGRAMMING SESSION CONTACT NUMBER 2 WAS SHOWING ABNORMAL AND ALL PAIRS WITH NUMBER 2 WERE GREATER THAN 40 ,000 OHMS. IT WAS NOTED THAT THEY WERE NOT PROGRAMMING ON NUMBER 2. IT WAS NOTED THAT THE PATIENT HAD GOOD EFFICACY DESPITE THE ISSUE WITH CONTACT NUMBER 2. IT WAS FURTHER NOTED THAT WHEN THE PATIENT DOES ¿ARM STRETCH AND REACHES RIGHT ARM OVER CHEST¿ HE FELT SHOCKING SENSATIONS THROUGHOUT THE RIGHT SIDE OF HIS BODY. IT WAS NOTED THAT IT ONLY OCCURRED ON GROUP B AND ONLY OCCURRED WITH THIS PARTICULAR MOVEMENT. IT WAS NOTED THAT GROUP A WAS 1-, 1.6 VOLTS, 90 ¿S, 185 HZ, AND C+. IT WAS FURTHER NOTED THAT GROUP B WAS INTERLEAVED AT 0-, C+, 60 ¿S, 125 HZ, AND 1-, C+, 90 ¿S, 125 HZ, AT 1.9 VOLTS. IT WAS NOTED THAT GROUP C WAS 3-, C+, 90 ¿S, 185 HZ, AND 3.4 VOLTS. IT WAS NOTED THAT THE PATIENT ONLY NOTICED THE SIDE EFFECT OF SHOCKING WITH GROUP B. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE THIS EVENT WHEN THE DEVICE WAS TURNED OFF. IT WAS NOTED THAT THE TEST AT 3.0 VOLTS SHOWED C0 3755, C1 1076, C2 >40000, C3 1082, 01 4569, 02 >40000, 03 5137, 12 >40000, 13 1620, 23 >40000. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WERE HIGH IMPEDANCE AND A SURGICAL INTERVENTION WAS PLANNED TO BE DONE ON (B)(6) 2015, IT WOULD BE AN EXPLORATORY SURGERY TO SEE IF THE ISSUE WAS THE BATTERY OR THE EXTENSION AND WOULD BE REPLACED AS NECESSARY. THEY WERE GOING TO OPEN THE POCKET AND THEN THE BATTERY EXTENSION CONNECTION TO TRY AND IDENTIFY THE PROBLEM. IMPEDANCE TESTING WAS DONE. THERE WAS A LOSS OF THERAPEUTIC EFFECT AND THE PATIENT HAD NOTICED THIS ISSUE AFTER HIS LAST BATTERY REPLACEMENT ALMOST 2 YEARS PRIOR TO THE DATE OF THIS REPORT. CONTACT 2 WAS SHOWING HIGH AND REPROGRAMMING HAD BEEN TRIED. FIRST THE GENERATOR WAS EXPLANTED AND IMPEDANCE OF THE EXTENSION WAS PERFORMED WITH AN EXTERNAL NEUROSTIMULATOR (ENS) WHICH HAD STILL SHOWN OPEN CIRCUITS. LEAD IMPEDANCE WAS CHECKED AND WAS SHOWING INTACT. THE INS AND EXTENSION WERE REPLACED, IMPEDANCES WERE NORMAL FOLLOWING REPLACEMENTS. THE PATIENT WAS RECEIVING GOOD THERAPY FOLLOWING PROCEDURE. THERE WERE NO OBVIOUS FRACTURES ON THE EXTENSION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD ONLY HAD ONE DEVICE FROM 2006 AND THERE WAS NOT A REPLACEMENT TWO YEARS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634420 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention