MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Citation: bienfait f, jubier-hamon s, seegers v, et al.First evaluation switching from ropivacaine to highly concentrated bupivacaine in intrathecal mixtures for cancer pain.Neuromodulation.2021.10.1111/ner.13469 age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: bienfait f, jubier-hamon s, seegers v, et al.First evaluation switching from ropivacaine to highly concentrated bupivacaine in intrathecal mixtures for cancer pain.Neuromodulation.2021.10.1111/ner.13469 abstract background: intrathecal drug delivery is widely used for intractable cancer pain treatment.A combination of drugs with morphine and bupivacaine is recommended in first line therapy.In france, we use ropivacaine 10 mg/ml instead of bupivacaine 5 mg/ml, the only concentration available.Bupivacaine 40 mg/ml has been available in france only since july 2020 under temporary authorization of use.Objectives: the main objective of the study was to evaluate the safety, efficacy by pain assessment, to analyze drug dosage changes, to report adverse events (aes) and conversion ratios switching from ropivacaine to bupivacaine.Secondary objective was to evaluate costs differences.Materials and methods: we conducted this retrospective follow-up monocentric study within the institut de cancérologie de l¿ouest (ico) pain department in angers, france.We included 14 patients aged 18 years and above, implanted with an intrathecal drug delivery systems (idds) for cancer pain treatment and followed up at ico from july 2020 to february 2021 after switching from ropivacaine to bupivacaine.We used a continuous infusion mode and bolus could be added through personal therapy manager (ptm).Results: the median conversion ratio between ropivacaine and bupivacaine was 0.68 (0.65; 0.69) and resulted in no significant change in numeric rating scale evaluation (p = 0.10).We observed moderate and rapidly reversible aes such as clinical hypotension (29%) and motor block after bolus (21%).The estimated median hospital cost per day was significantly lower (p = 0.05) for the bupivacaine refills than for the last ropivacaine pump refill, decreasing from us$ 61.7 (49.6; 70.5) to us$ 50.4 (45.9; 60.4).The median reimbursement per day from the national health insurance (nhi) was three times lower for bupivacaine pump refill when compared to the last ropivacaine pump refill (p <(><<)> 0.01), decreasing from us$ 179.10 (156.79; 182.91) to us$ 64.59 (59.85; 71.89).Conclusion: switching from ropivacaine to bupivacaine in idds appears more efficacious while remaining just as secure, and at lower cost   reported events: we observed only moderate and rapidly reversible aes.Aes occurred in seven patients out of 14 after the switch, one patient sometimes reporting multiple aes.The most common reported adverse event was clinical hypotension (four cases, 29%), then motor block after bolus (three cases, 21%) and finally nausea after bolus, or drowsiness (one case of each, 7%).No motor block occurred with the continuous pump flow infusion, and all bolus-related and basal flow related aes were rapidly resolutive and did not occur again after respective adaptations of bolus parameters (decrease of bolus volume or increase in time for bolus) or basal flow.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 12599203
• MDR Text Key: 281510117
• Report Number: 2182207-2021-01756
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR