MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problems
Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)
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Patient Problems
Overdose (1988); Pain (1994); Therapeutic Response, Decreased (2271); Loss of consciousness (2418); Lethargy (2560)
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Event Date 04/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(4) 2011, product type: catheter.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-may-2013, (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) and manufacturer representative (rep) regarding a patient who was receiving 20 mg/ml dilaudid at 2 mg/day, 700 mcg/ml clonidine at 70 mcg/day, and 21 mg/ml bupivacaine at 2.1 mg/day via an implantable pump for non-malignant pain.It was reported that on the night of (b)(6) 2018, the patient had been using their personal therapy manager (ptm) overnight and it was not relieving her pain like it usually did.On wednesday [(b)(6) 2018], the patient fell asleep and the daughter could not wake her up.The patient had a second incident on thursday where she fell asleep in the emergency room and the doctors had a hard time arousing her.It was noted that the expected residual volume was 17 ml and the actual residual volume was 0 ml.It was stated that the physician believed these were instances of overdose and that was why the pump was empty.The patient's refill was a month or more ago.They aspirated the reservoir and filled with preservative free normal saline and a bridge bolus was programmed around 11:45 pm saturday night.It was noted they were unable to aspirate the catheter.The rep was going to speak with the patient and decide whether they were going to replace the pump.Withdrawal was also noted.The patient was being given oral medication, but it was not making a dent on the pain.The patient was noted to be in the hospital with iv medication.It was later reported that the hcp wanted to restart the pump with the "normal medication dosage" and wanted to know how much drug was left in the catheter.No further issues were reported or anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a healthcare professional (hcp).No cause of the volume discrepancy was determined.The cause of the inability to aspirate was also unknown.10 ml of saline was inserted into the pump and a bridge bolus was initiated and the event was considered to be resolved.The device was working well and the refill was done.No further issues were reported or anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare professional (hcp) and manufacturer representative (rep) regarding a patient who was receiving 20 mg/ml dilaudid at 2 mg/day, 700 mcg/ml clonidine at 70 mcg/day, and 21 mg/ml bupivacaine at 2.1 mg/day via an implantable pump for non-malignant pain.It was reported that on the night of (b)(6)2018, the patient had been using their personal therapy manager (ptm) overnight and it was not relieving her pain like it usually did.On wednesday [(b)(6)2018], the patient fell asleep and the daughter could not wake her up.The patient had a second incident on thursday where she fell asleep in the emergency room and the doctors had a hard time arousing her.It was noted that the expected residual volume was 17 ml and the actual residual volume was 0 ml.It was stated that the physician believed these were instances of overdose and that was why the pump was empty.The patient's refill was a month or more ago.They aspirated the reservoir and filled with preservative free normal saline and a bridge bolus was programmed around 11:45 pm saturday night.It was noted they were unable to aspirate the catheter.The rep was going to speak with the patient and decide whether they were going to replace the pump.Withdrawal was also noted.The patient was being given oral medication, but it was not making a dent on the pain.The patient was noted to be in the hospital with iv medication.It was later reported that the hcp wanted to restart the pump with the "normal medication dosage" and wanted to know how much drug was left in the catheter.No further issues were reported or anticipated.Additional information was received from a healthcare professional (hcp).No cause of the volume discrepancy was determined.The cause of the inability to aspirate was also unknown.10 ml of saline was inserted into the pump and a bridge bolus was initiated and the event was considered to be resolved.The device was working well and the refill was done.No further issues were reported or anticipated.
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Search Alerts/Recalls
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