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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving morphine of an unknown concentration at an unknown dose rate via an implantable pump.It was reported that during the patients last refill the pump was found to have 33 ml of residual drug in the reservoir, when only 11 ml should have been present.The pump was found to be mobile when palpated.Factors that may have led or contributed to the issue were unknown.A revision surgery was scheduled to occur on (b)(6) 2022.The issue was not resolved as of (b)(6) 2022.The patient was without injury regarding their status as of (b)(6) 2022.The patient's medical history, age, and weight at the time of the event was unknown or would not be made available.

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot#: 0222253445, implanted: (b)(6) 2021, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 14-mar-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H6: the previously applied method code b20 remains applicable to the pump.The method code b18 pertains to the 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 a foreign healthcare provider via a company representative.A revision was performed on 2022-mar-23.The pump had flipped many times and so the pump segment of the catheter was replaced.The cause of the pump having been mobile / flipped was not determined.The cause of the volume discrepancy was due to the catheter having become kinked, preventing the normal delivery of drug.The issue / volume discrepancy at refill, and pump having been mobile in the pocket was resolved.The pump remained implanted.The healthcare provider had discarded the twisted catheter segment (pump segment).

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13825693
• MDR Text Key: 290158105
• Report Number: 3004209178-2022-03464
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Date Device Manufactured: 05/14/2021
• 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
• Treatment: SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Sex: Female