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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) and a consumer via a company representative regarding a patient receiving morphine (40 mg/ml at 17 mg/day) and bupivacaine (40 mg/ml at 17 mg/day) via an implanted pump.The indication for pump use was malignant pain.It was reported that the patient¿s pump was intermittently stalling and recovering.Per the pump logs, there were a number of relatively short duration motor stalls with motor stall recoveries noted soon after.The patient was still able to use his ptm (personal therapy manager) to get boluses and reported no problems with the therapy.He was in hospice with stage 4 cancer.The reporter was advised to inquire about any possible emi (electromagnetic interference) or magnetic sources in the environment and eliminate them if possible.Additional information was received on (b)(6) 2021 from the patient via the company representative who reported that the patient was advised to avoid placing anything over his pump that could potentially cause a motor stall.The patient stated that he may have placed his iphone 7 over his pump at times and had placed his cadd pump over his implanted pump at times as well.The patient had previously reported that the pump made noises and his ptm showed a code 100 (motor stall) and he had heard his pump alarm a few times since then but there were no more error messages when using the ptm.

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.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 company representative.The cause of the motor stalls was undetermined.It was further noted though that the patient was putting his cad pump over their infusion pump an since he quit doing this he had not had any further stalls to date.Regarding actions taken, the patient was educated to not put any other electronic or magnetic device over the pump.The pump remains implanted.

• 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: 11819385
• MDR Text Key: 250641892
• Report Number: 3004209178-2021-07654
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 45