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

Model Number 8637-20

Device Problems Kinked (1339); Unstable (1667); Aspiration Issue (2883); Material Integrity Problem (2978)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id; 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(4) 2016, (b)(4).Applies to the catheter.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 company representative (rep) regarding a patient receiving intrathecal unknown morphine ¿40¿ at ¿10.8¿ via an implanted pump for chronic low back pain and non-malignant pain.It was asked and unknown when the event/difficulty occurred.The pump segment was partially explanted/replaced on (b)(6) 2018 and would be returned.It was noted the patient had a lack of efficacy for an unknown time period.The office tried to fill the pump on (b)(6) 2018 and under x-ray saw it was flipped.On the date of this report, ¿it flipped back, but the catheter was twisted and kinked.¿ it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.The x-ray showed flipped pump yesterday and they were unable to aspirate during surgery on (b)(6) 2018.The pump flipped several times and twisted the catheter.Actions/interventions taken to resolve the issue included a new pump segment.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury.¿ other medications the patient was taking at the time of the event were unable to be obtained.The patient¿s weight and medical history were ¿asked and would not be made available.¿ no further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) indicated the cause of the pump flipping was unknown.Actions/iinterventions taken to resolve the pump flip included re-entry to the pocket to unflip and suture.The patient's weight at the time of the event was (b)(6) pounds.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Analysis of the catheter found damage to the transition tube of the catheter body.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7371066
• MDR Text Key: 103482516
• Report Number: 3004209178-2018-05743
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 61