BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2201347 · Received August 3, 2011

    Report

    Report Number
    3004209178-2011-06021
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR MODEL 7427V SERIAL# (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE DEVICE FAILED THE AUTOMATED TEST CONSOLE AS THE BATTERY WAS NOT IN NEW CONDITION. A TELEMETRY TESTED OKAY AND GOOD STABLE OUTPUT WAS OBSERVED ON ALL ELECTRODE PAIRS.

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3487A LOT# J0309645V EXPLANTED: (B)(6) 2012; EXTENSION MODEL 7495-25 LOT# NAF019204N EXPLANTED: (B)(6) 2012, EXTENSION MODEL 7495LZ LOT# NHK021378V EXPLANTED: (B)(6) 2012; LEAD MODEL 3487A LOT# J0309645V EXPLANTED: (B)(6) 2012. ANALYSIS OF THE LEAD MODEL 3487A LOT# J0309645V FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY INSULATION AND CONDUCTORS HAD BEEN CUT THROUGH. THE CONDUCTORS HAD ALSO BEEN STRETCHED. THE LEAD WAS SEGMENTED. THERE WERE NO SHORTS BETWEEN CIRCUITS AND CONTINUITY WAS ACCEPTABLE WHEN THE CUT PROXIMAL SEGMENT OF THE LEAD WAS TESTED WITH THE CUT EXTENSION. ANALYSIS OF THE EXTENSION MODEL 7495-25 (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE BODY INSULATION AND CONDUCTORS WERE CUT THROUGH. THE EXTENSION WAS SEGMENTED. THE DISTAL SEGMENT WAS TESTED WITH THE CUT LEAD; CONTINUITY WAS ACCEPTABLE WITH NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF THE EXTENSION MODEL 7495LZ25 (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE BODY INSULATION AND CONDUCTORS WERE CUT THROUGH. THE EXTENSION WAS SEGMENTED. CONTINUITY WAS ACCEPTABLE WITH NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF THE LEAD MODEL 3487A LOT# J0309645V FOUND THE #6 CONDUCTOR WIRE WAS BROKEN IN THE BODY OF THE LEAD 9CM FROM THE DISTAL END. AN OPEN CIRCUIT WAS IDENTIFIED AT #6. CONTINUITY WAS ACCEPTABLE ON #4, #5, AND #7. THERE WERE NO SHORTS BETWEEN CIRCUITS. THE BODY INSULATION HAD BEEN CUT THROUGH AND THE LEAD WAS SEGMENTED. THE PROXIMAL SEGMENT WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THERE WAS NO STIMULATION TO THE RIGHT ARM. THE PT FELT STIMULATION IN HER LEFT ARM. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. FOR RESULTS DURING THE IMPEDANCE CHECK QUESTION MARKS (???) WERE RECEIVED. AT 3.0V AND PW OF 450 THE IMPEDANCES WERE AS FOLLOWS: 0-1=682, 0-2=862, 0-3=862, 0-4=862, 0-5=762, 0-6=2354, 1-2=762, 1-3=858, 1-4=862, 1-5=???, 1-6=2354, 1-7=862, 2-3=762, 2-4=???, 2-5=862, 2-6=2354, 2-7=858, 3-4=862, 3-5=862, 3-6=2354, 3-7=986, 4-5=682, 4-6=2330, 4-7=990, 5-6=1758, 5-7=862, 6-7=2330. ALL COMBINATIONS WITH ELECTRODE 6 HAD HIGHER IMPEDANCES. PT WAS PROGRAMMED TO 1- AND 2+ FOR LEFT ARM AND 5- AND 6+ FOR RIGHT ARM. WHEN PROGRAMMING WAS CHANGED TO 4 AND 5 PT REPORTED FEELING STIMULATION IN RIGHT ARM AGAIN. PT WAS RECEIVING STIMULATION IN HER RIGHT ARM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN SCHEDULED FOR NEUROSTIMULATOR REPLACEMENT DUE TO NORMAL BATTERY DEPLETION. DUE TO THE SITE AND PLACEMENT OF THE NEUROSTIMULATOR (SUBSCAPULAR PLACEMENT OF THE NEUROSTIMULATOR, CERVICAL PLACEMENT OF THE LEADS) THE PHYSICIAN DID NOT THINK A RESTORE PRIME WITH ADAPTOR WOULD FIT IN THE PATIENT'S EXISTING POCKET. THE PHYSICIAN AND PATIENT AGREED TO REMOVE ALL COMPONENTS OF THE SYSTEM AND REIMPLANT WITH A RESTORE PRIME NEUROSTIMULATOR AND NEW LEADS. REMOVAL AND REPLACEMENT WERE DONE WITHOUT INCIDENT. THE PATIENT RECEIVED GOOD STIMULATION COVERAGE POST-OP AND RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT STIMULATION WAS TURNING OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT007410P| LEAD: MODEL 3487A, LOT# J0309645V| IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK021378V| EXTENSION: MODEL 7495-25, LOT# NAF019204N| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0309645V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: