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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964); Mechanics Altered (2984)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a company representative (rep) regarding a patient receiving intrathecal morphine 20 mg/ml at 24 mg/day via an implanted pump for spinal pain.The event/difficulty occurred on (b)(6) 2018 during normal use and a motor stall occurred.The pump would be replaced on (b)(6) 2018 and would be returned.There were no environmental/external/patient factors that may have led or contributed to the issue and diagnostics/troubleshooting performed included reading the pump with the 8840 clinician programmer.It was noted 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 obtain, not available.The patient¿s weight and medical history were asked and unknown and would not be made available due to (legal/confidential reason).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) via a company representative (rep) indicated there was no flow when aspiration was attempted and the cause of the no flow was unknown.The cause of the motor stall was also unknown.It was noted the pump, 8596sc, and 8709 were discarded.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 8709, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2018, product type: catheter; product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2018, product type: catheter, the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 19-sep-2009, udi#: (b)(4), product id: 8596sc, serial/lot #: (b)(4), ubd: 10-may-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative (rep) indicated the pump was replaced on (b)(6) 2018 and it was found that there was no flow in the catheter and that was also replaced.The dose was decreased from 24 mg/day to 2 mg/day.No further complications were reported/anticipated or expected.

• 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: 7724502
• MDR Text Key: 115187828
• Report Number: 3004209178-2018-16786
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 07/27/2018; 07/30/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/30/2018; 08/07/2018; 10/04/2018; 10/04/2018
• Date Device Manufactured: 04/08/2014
• 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 Age: 53 YR