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

Model Number 8637-40

Device Problems Nonstandard Device (1420); Pumping Stopped (1503); Mechanical Jam (2983)

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

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter: physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving clonidine (500 mcg/ml at 200 mcg/day), bupivacaine (20 mg/ml at 8 mg/day), baclofen (800 mcg/ml at 320 mcg/day), and dilaudid (25 mg/ml at 10 mg/day) via an implanted pump.The indication for pump use was failed back surgery syndrome and spinal pain.It was reported that a motor stall was seen at initial interrogation on (b)(6) 2018.The patient had not recently had an mri.The pump logs indicated a motor stall occurred.The pump logs also showed multiple motor stalls and recoveries and a stopped pump period may exceed tube set message.The patient was going to have the pump replaced on monday ((b)(6) 2018), but her ¿lab work was bad¿, so they postponed until today ((b)(6) 2018) and were planning to replace the pump provided they could get the patient on the schedule.No patient symptoms were reported.No further complications have been reported as a result of this event.

Manufacturer Narrative

Corrected information.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7718653
• MDR Text Key: 114986477
• Report Number: 3004209178-2018-16593
• Device Sequence Number: 1
• Product Code: LKK
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 10/14/2013
• 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: 07/25/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 04/26/2012
• 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-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR