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

Model Number 8637-40

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 300 mcg/ml of clonidine at 108.19 mcg/day and 20 mg/ml of morphine at 7.213 mg/day via an implantable pump for non-malignant pain.On (b)(6) 2017, it was reported that a pump motor stall occurred when the patient had an mri on (b)(6) 2017 and the stall had not recovered.The hcp reported that the patient had an mri on (b)(6) 2017 at 11:33 and, during a refill the following day, it was noted that the motor stall had occurred.The hcp confirmed that the motor stall occurred on (b)(6) 2017 at 11:33, the same time the patient was having the mri.The pump alarm was heard after the pump was interrogated.According to the hcp, no recovery was noted both 10 and 15 minutes after the initial interrogation.No symptoms were reported and no further complications were reported.

Manufacturer Narrative

Corrected information: sex, date of birth.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: 6638622
• MDR Text Key: 77628818
• Report Number: 3004209178-2017-12815
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• 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: 05/25/2017
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0592-2009
• Patient Sequence Number: 1
• Patient Age: 67 YR