| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TOF WATCH SX | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC | ORGANON IRELAND LIMITED | KOI | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-12-11 | 0 |
Patient 1
THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH SX) WAS AVAILABLE FOR INVESTIGATION (CURRENT LOCATION OF THE DEVICE IS (B)(6)). FOR NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH SX), THE LOT NUMBER IS NOT AVAILABLE AND THE SERIAL NUMBER WAS REPORTED AS (B)(4). FOR NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH SX), QUALITY INVESTIGATION STATUS: REPORTABLE MALFUNCTION/POTENTIAL INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. ADD'L INFO IS EXPECTED.
Patient 1
CASE DESCRIPTION: THIS SPONTANEOUS INITIAL REPORT ORIGINATING FROM (B)(6) AS RECEIVED FROM A PHYSICIAN VIA A STUDY COORDINATOR, REFERS TO A (B)(6) FEMALE PT. THE PT WAS ENROLLED IN THE STUDY ENTITLED (B)(6) TRIAL TO COMPARE THE USE OF DEEP OR STANDARD NEUROMUSCULAR BLOCKADE IN COMBINATION WITH LOW OR STANDARD INSUFFLATION PRESSURES USING A 2X2 FACTORIAL DESIGN IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY (PROTOCOL # (B)(4) ALSO KNOWN AS (B)(4)). THIS REPORT CONCERNS ONE PT AND ONE DEVICE. THE PT USED NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH SX) FROM (B)(6) 2013" (PRODUCT USED FOR UNK INDICATION). THE STUDY SITE RANDOMIZED THE PT ON (B)(6) 2013, BUT THERE WERE PROBLEMS WITH THE NEUROMUSCULAR TRANSMISSION MONITOR (TOF WATCH SX). THE STUDY COORDINATOR MANAGED TO DO CALIBRATION BUT AFTER THAT THEY HAD SOME DIFFICULTIES WITH TOF MEASUREMENTS AND THEN SUDDENLY IN THE TOF WATCH SCREEN APPEARED AN IMAGE OF WRENCH AND ERROR MESSAGE. THE DEVICE WAS CONNECTED TO THE PT AT THE TIME OF THE EVENT. THEN THE DEVICE TURNED OFF BY ITSELF AND DID NOT WORK ANYMORE. BEFORE THIS, NOTHING HAPPENED WHICH COULD EXPLAIN THIS HAPPENED. NEW BATTERY WAS ALSO CHANGED. THE DEVICE WAS USED ACCORDING TO THE INSTRUCTION LEAFLET. INFO ON THE OPERATOR OF THE DEVICE IS NOT REPORTED, HOWEVER, THE OPERATOR WAS TRAINED.