MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The event date is approximate for this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturing representative (rep) regarding a patient receiving 40 mg/ml of dilaudid at 30 mg/day via an implantable pump.The patient reported not consistently hearing the pump alarm for low reservoir.It was reported the patient contacted the rep on 2020-dec-15 and told them at the refill before their last refill the pump was supposed to have 1 ml of drug and there was 4 ml.The patient's alarm date was saturday, but the patient reported they did not hear the pump alarm until monday, and it did not alarm every hour.The patient heard the alarm only twice, he never heard it every hour.The pump was refilled 2020-dec-15 and it was reported the pump was supposed to have 0.5 ml and the pump had 1 ml of drug.The patient was concerned that the they were not hearing the alarm every hour when they normally hear the alarm pretty well.The rep was going to see the patient 2020-dec-16 and read the logs.It was noted the patient reported experiencing increased pain that started about a month earlier.The patient's wife said the increased pain had been for this whole year.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information received from an hcp via a manufacturer representative indicated that the pump was interrogated as planned.According to the patient, the low reservoir alarm was supposed to occur on (b)(6) 2020, but the alarm actually occurred on (b)(6) 2020 at 12:55pm.The pump was interrogated after the refill on (b)(6) 2020 and the non-critical alarm was set to occur every hour.It w as unknown if the alarm issue was resolved.No troubleshooting was performed to determine the cause of the volume discrepancy and the cause of the discrepancy was unknown.The patient was to be scheduled for a catheter dye study.It was unknown if the alarm issue was resolved and the volume discrepancy was not resolved.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11031007
• MDR Text Key: 223139721
• Report Number: 3004209178-2020-22138
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR