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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem (2880); Positioning Problem (3009)

Patient Problems Memory Loss/Impairment (1958); Overdose (1988); Malaise (2359); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Date 05/21/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a family member/friend and patient who was receiving baclofen at an unknown concentration at 550-570mcg/day via an implantable infusion pump for intractable spasticity.It was reported that there are rare episodes where it feels like the patient is getting an extra bolus dose.The patient will experience mental confusion, short term memory loss, and doesn't feel right.It is reported that the episodes last around 10 minutes and they are rare to infrequent, but it has happened twice when traveling.Recently, it happened to the patient while they were sitting at the table.The patient reported they occasionally take motrin.It was reported that the issue started a year ago relative to (b)(6) 2018.The patient reported their pump sticks out, and since they recently lost weight the pump sticks out even more.The patient reported the pump had stuck out since the implant.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the issue was resolved.No further complications were anticipated/reported.

Manufacturer Narrative

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: 7731824
• MDR Text Key: 115405888
• Report Number: 3004209178-2018-16927
• 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: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,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: 09/14/2015
• 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: 07/02/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/27/2018; 08/08/2018
• Supplement Dates FDA Received: 09/05/2018; 10/04/2018
• Date Device Manufactured: 03/19/2014
• 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-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR