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

Model Number 8637-40

Device Problem Kinked (1339)

Patient Problem Muscular Rigidity (1968)

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8598a, serial# (b)(4), product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2000mcg/ml gablofen at 500mcg/day via an implantable infusion pump for intractable spasticity and cerebral palsy.It was reported that the catheter was kinked.The issue was diagnosed during surgical exploration.It was reported that the patient had episodic spasticity which had been happening for several months.The catheter was revised and the pump was also electively replaced since it had two years left of longevity.It was reported there were no issues with the pump.During the revision once the catheter was straightened fluid started dripping.The hcp requested numbers for priming the system.The hcp believed that the patient had a total catheter length of 81cm.No further complications were anticipated/reported.

Manufacturer Narrative

References the main component of the device system; the other relevant components include: product id 8598a, serial# (b)(4), product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional info was received from a healthcare provider.It was reported the cause of the kinked catheter was unknown.It was reported that the kinked catheter was resolved.No further complications were anticipated/reported.

• 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: 7160504
• MDR Text Key: 96325577
• Report Number: 3004209178-2018-00131
• 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
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Date Device Manufactured: 05/13/2013
• 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