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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Improper Flow or Infusion (2954)

Patient Problems Pain (1994); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving morphine (40 mg/ml at 8 mg/day) via an implantable pump.It was reported that the patient's pump was refilled on (b)(6) 2022 and the following day, the patient was in intensive care unit because of overdose symptoms.Factors that may have led or contributed to the issue was noted as being not applicable.The healthcare provider who performed the refill was sure they didn't refill the pump pocket.The pump was first put in a minimal rate.The patient was reactive.The pump was emptied on (b)(6) 2022 and there was 10 ml removed instead of approximately 10 ml.The healthcare provider decided to shut down the pump (definitive) and to deal with the patient symptoms with other treatments.The healthcare provider was informed that the pump would not be able to work again and that the overdose / withdrawal symptoms had to be taken in charge.The issue was not resolved as of (b)(6) 2022.The pump remained implanted and out of service.No surgical intervention occurred and it was unknown if surgical intervention was planned.The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.

Manufacturer Narrative

D6b: the date (b)(6) 2022 is considered an approximate explant date (specific year known only).H6 update: the previously applied device code a1405 is no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign healthcare provider via a company representative.The pump serial number and implant date were unknown / unable to be provided.Regarding the volume discrepancy, it was clarified that the healthcare provider should have removed 18 ml and only 10 ml was removed.There was no significant volume discrepancy at the previous refill.The cause of the event / overdose symptoms was not determined.The pump was permanently shut down and an iv relay was put in place.Some weeks later, the pump was explanted and not replaced.The date (b)(6) 2022 is considered an approximate date of explant (specific year known only).The patient was fine and was still having pain symptoms.The patient was currently being reevaluated to better understand her symptoms and which treatment should be put in place.Regarding if the pump would be returned for analysis, the physician did not know the location of the device.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13537258
• MDR Text Key: 288381493
• Report Number: 2182207-2022-00261
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female