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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Pain (1994); Therapeutic Effects, Unexpected (2099); Sweating (2444)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer¿s device registration system indicates the device system was replaced.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare professional (hcp) via a company representative regarding a patient receiving morphine sulfate (10 mg/ml) via an implanted pump.On (b)(6) 2020 it was reported that the patient had had insufficient therapy since the revision/replacement procedure in (b)(6) 2020.His pain was still the same as it was prior to the original implant and he had been experiencing diarrhea and frequent sweating since prior to the revision procedure in february.There were no external factors that contributed to the issue.On (b)(6) 2020, a dye study was done and there was no device issue found.The catheter was intact with no issues.A perfect myelogram was formed by the dye in the intrathecal space according to the physician.The physician then increased the patient¿s daily dose by 20% (from 1.440 mg/day to 1.726 mg/day) and the patient¿s symptoms, according to the patient, had resolved as of (b)(6) 2020.The cause of the symptoms was not determined.Additional information was received, and it was reported that the patient had never gotten good therapy since his revision back in (b)(6) 2020, so he was taken to the or (operating room) on 02-oct-2020.At the time of the report the patient was still in the or and they had done a dye study and it was negative and there were no stalls in the logs and no volume discrepancies had been seen.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6)2018 explanted: (b)(6)2020 product type catheter pro duct id 8784 lot# serial# (b)(6) implanted: (b)(6)2020 explanted: (b)(6)2020 product type catheter.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 the healthcare provider via the device manufacturer representative indicated that the device was functioning perfectly normal and no issues were found.

• 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: 10641820
• MDR Text Key: 210188199
• Report Number: 3004209178-2020-17396
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR