| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | APS? (AUTOMATIC PERIODIC STIMULATION) ELECTRODE | ELECTRODE, NEEDLE | MEDTRONIC XOMED INC. | GXZ | 8228052 | 8228052 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-17 | 0 | 1. O |
Patient 1
CONCOMITANT MEDICAL PRODUCTS: (1) UNKNOWN NIM 3.0 SYSTEM (UNK. PROD. ID/ NIM); SN: UNKNOWN; MANUFACTURED: UNKNOWN; 510K: UNKNOWN. (B)(4). THIS DEVICE IS BEING REPORTED FROM A LITERATURE REVIEW. NO DEVICES WILL BE RETURNED, THEREFORE NO EVALUATION COULD BE PERFORMED. (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.
Patient 1
FROM THE ARTICLE PUBLISHED IN THE "WORLD JOURNAL OF SURGERY" ON JULY 3, 2015 ENTITLED "CONTINUOUS VAGAL NERVE MONITORING IS DANGEROUS AND SHOULD NOT ROUTINELY BE DONE DURING THYROID SURGERY,�Y DAVID J. TERRIS; KATRINA CHAUNG; WILLIAM S. DUKE. THE ARTICLE DISCUSSED A NON-CONTROLLED TRIAL OF CONTINUOUS VAGAL NERVE MONITORING (CVNM). THE STUDY WAS CONDUCTED BETWEEN FEBRUARY 26, 2014 AND JUNE 25, 2014 ON 9 NON-RANDOMLY SELECTED PATIENTS UNDERGOING THYROID AND PARATHYROID SURGERY. IN EVENT 1 OUT OF 2 TOTAL EVENTS (EVENT 2 WILL BE REPORTED ON MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)), IT WAS REPORTED THAT A MEDTRONIC 2MM APS ELECTRODE USED WITH THE NIM 3.0 SYSTEM CAUSED "HEMODYNAMIC INSTABILITY" ON A (B)(6) FEMALE INTRAOPERATIVELY. ALTHOUGH THERE WERE NO HEMODYNAMIC ABNORMALITIES DURING THE PROCESS OF IDENTIFICATION AND DISSECTION OF THE VAGUS NERVE...SHORTLY AFTER BASELINE CALIBRATION OF THE APS ELECTRODE IS WHEN THE HEMODYNAMIC INSTABILITY OCCURRED, MANIFESTED AS BRADYCARDIA AND HYPOTENSION. HEMODYNAMIC STABILITY WAS PROMPTLY REESTABLISHED WHEN THE APS ELECTRODE WAS REMOVED...UPON A SECOND ATTEMPT TO ESTABLISH CVNM, AN IDENTICAL HEMODYNAMIC RESPONSE QUICKLY FOLLOWED PLACEMENT OF THE APS ELECTRODE AGAIN AND REVERSED PROMPTLY WHEN THE ELECTRODE WAS REMOVED. AS A RESULT, CVNM WAS ABANDONED FOR THE REMAINDER OF THE SURGERY WITH NO OTHER EPISODES OF HEMODYNAMIC INSTABILITY OBSERVED...IT WAS NOTED THAT HEMODYNAMIC INSTABILITY WAS RELATED TO THE INCREASED PARASYMPATHETIC TONE CAUSED BY THE VAGAL STIMULATION. THERE WAS NO REPORT OF PERMANENT PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.