BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2810361 · Received October 31, 2012

    Report

    Report Number
    3007566237-2012-02595
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 27, 2011
    Report Date
    October 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A, SERIAL# UNKNOWN, PRODUCT TYPE. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    PEYRAVI, M., CAPELLE, H. H., FISCHER, S., HAVERICH, A., KRAUSS, J. K. SUBCUTANEOUS PERIPHERAL NEUROSTIMULATION FOR THE TREATMENT OF SEVERE CHRONIC POSTSTERNOTOMY NEURALGIA. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2011;89(4):253-257. DOI: 10.1159/000328271. SUMMARY: POSTSTERNOTOMY PAIN FREQUENTLY DEVELOPS AFTER STERNOTOMY IN THORACIC AND CARDIOVASCULAR SURGERY, AND MAY AFFECT PATIENTS' QUALITY OF LIFE. IN SOME CASES OF SEVERE POSTSTERNOTOMY NEURALGIA, PHARMACOLOGIC THERAPY DOES NOT PROVIDE ADEQUATE RELIEF. WE REPORT ON A (B)(6) WOMAN WHO UNDERWENT STERNOTOMY FOR AORTIC AND MITRAL VALVE REPLACEMENT. SHE DEVELOPED SEVERE CHRONIC POSTSTERNOTOMY NEURALGIA THAT WAS REFRACTORY TO MEDICAL TREATMENT. AFTER LOCAL ANESTHESIA MARKEDLY BUT ONLY TRANSIENTLY ALLEVIATED PAIN, WE CONSIDERED THE OPTION OF SUBCUTANEOUS PERIPHERAL NEUROSTIMULATION (SPNS). PLATE ELECTRODES WERE IMPLANTED BILATERALLY IN THE PARASTERNAL REGION AT THE SITE OF MAXIMAL PAIN. AFTER A PERIOD OF TEST STIMULATION, THE ELECTRODES WERE CONNECTED TO A DUAL-CHANNEL IMPLANTABLE PULSE GENERATOR. SPNS INDUCED PARESTHESIAS IN THE PAINFUL AREA. REVISION SURGERY WAS NECESSARY TWICE BECAUSE OF ELECTRODE MIGRATION. CHRONIC SPNS MARKEDLY ALLEVIATED PAIN (VISUAL-ANALOG SCALE, VAS, 9/10 PREOPERATIVELY, 2/10 POSTOPERATIVELY) AND ALLODYNIA (VAS 9/10 PREOPERATIVELY, 2/10 POSTOPERATIVELY) AT THE LAST AVAILABLE FOLLOW-UP, 15 MONTHS POST OPERATIVELY. SPNS MAY BE A VIABLE TREATMENT OPTION IN PATIENTS WITH SEVERE CHRONIC POSTSTERNOTOMY NEURALGIA. REPORTED EVENT: A 42 YEAR OLD FEMALE EXPERIENCED INADEQUATE PAIN RELIEF AND DOWNWARD LEAD MIGRATION AT 5 AND 10 MONTHS POSTOPERATIVELY. IN BOTH CASES, THE ELECTRODE WAS CORRECTED UNDER GENERAL ANESTHESIA. DURING THE SECOND REVISION, THE ELECTRODE WAS FIXED WITH NONRESORBABLE SUTURES TO THE FASCIA AT THE LATERAL STERNUM. EFFECTIVE PARESTHESIA WAS ATTAINED AFTER BOTH REVISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention