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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Twiddlers Syndrome (2114); Anxiety (2328)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 05-mar-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative on 2020-may-04 regarding a patient receiving morphine (20mg/ml at 8.437mg), bupivacaine (10mg/ml at 4.218mg), and clonidine (300mcg/ml at 126.55mcg) via an implanted infusion pump.It was reported that the patient was at the hospital complaining of anxiety and the hcp wanted to explore.A catheter revision was scheduled for (b)(6) 2020.The exact issue was unknown and the environmental, external, or patient factors that may have led to the issue were unknown.The pump was interrogated and logs were fine.The issue was unresolved at the time of report and the patient's status was alive - no injury.No further complications were reported or anticipated.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.The device codes have been updated for this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).It was reported on (b)(6) 2020, the patient had a catheter revision.The piece in the pocket was swapped out with a new 8784 catheter.The catheter was all twisted and kinked.The catheter aspirated nicely once fixed.

Event Description

Additional information was received from the manufacturing representative (rep).The rep reported it was thought patient may rub their catheter in their sleep causing this issue.The surgeon wanted the patient to wear an abdominal binder to bed each night to prevent the patient from twiddling their catheter unconsciously in their sleep.The patient's anxiety resolved with continued therapy after the catheter revision.The explanted catheter portion was discarded, therefore, it would not be returned for analysis.It was confirmed the information provided had been confirmed with the physician/account.

Manufacturer Narrative

Concomitant medical product: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: product type catheter h6: the code method has been changed to 4115 for this 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: 10029404
• MDR Text Key: 190028825
• Report Number: 3004209178-2020-08179
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR