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); Mechanics Altered (2984)

Patient Problem Pain (1994)

Event Date 07/24/2018

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 healthcare provider regarding a patient who was receiving hydromorphone, bupivacaine, and baclofen via an implantable pump for non-malignant pain and post laminectomy pain.The following medications were currently being administered: hydromorphone with concentration 5 mg/ml at a dose rate of 1.9183 mg/day, bupivacaine with concentration 10 mg/ml at a dose rate of 3.837 mg/day, and baclofen with concentration 40 mcg/ml at a dose rate of 15.346 mcg/day.It was reported that a motor stall was seen at initial interrogation.The patient did not recently have an mri (magnetic resonance imaging).The following multiple motor stalls and recoveries occurred: motor stall occurred on (b)(6) 2018, motor stall recovery occurred (b)(6) 2018, and motor stall occurred (b)(6) 2018.The patient experienced pain.The change in therapy/symptoms occurred suddenly.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Update: the initial report indicated a the type of reportable event was malfunction and has since been updated to indicate serious injury instead regarding the additional information received.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider.The last motor stall did not recover, and the pump had reached tube set.The cause of the multiple motor stalls was note determined.The pump was explanted and replaced on (b)(6) 2018.

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): 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: 7746837
• MDR Text Key: 116722641
• Report Number: 3004209178-2018-17343
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• 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

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• 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: 08/08/2018
• Date Device Manufactured: 11/21/2012
• 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: 63 YR