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

Model Number 8637-40

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: a820, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020, information was received from a patient receiving an unknown drug via an implantable pump.The patient reported they were originally scheduled for a refill on (b)(6) 2020 but it was cancelled due to the medication not being delivered due to the holiday.The hcp made another appointment for refill on monday.The patient has received an alert on their personal therapy manager (ptm) saying that their reservoir was low.The patient alleged they didn¿t hear an alarm coming from the pump.No symptoms or patient complications reported.

Event Description

Additional information was received via a consumer.The patient was seeing an alarm code on their personal therapy manager (ptm) again since (b)(6) 2020.The ¿low reservoir alarm ¿ pump refill may be needed service code 97¿ was indicated.The pump was refilled on 2020-sep-09.Back pain had started on (b)(6) 2020.The patient was not scheduled to see their healthcare provider until (b)(6) 2020.The pump was noted as having administered hydromorphone of an unknown concentration at a dose rate of 4.54 mg/day.At the time of the report it was suggested that the patient could contact their hcp about their return of pain and to request to have the pump checked.

Manufacturer Narrative

H6 correction: the device code c63318 was previously reported in error.H10: review of this mdr and/or additional information received shows that there was no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury.No addition supplemental reports are required unless additional information received indicates a reportable event.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.

• 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: 10518097
• MDR Text Key: 206585458
• Report Number: 3004209178-2020-15728
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 69 YR