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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2013, explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), (b)(6), (b)(4).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 manufacturer representative (rep) regarding a patient who was receiving 7.5 mg/ml bupivacaine at 2.210 mg/day and 40 mg/ml morphine at 11.792 mg/day via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported that the hcp believed the spinal segment was occluded due to no adequate pain relief.The event date was unknown.The hcp was planning a revision for the spinal segment on (b)(6) 2018.It was noted the physician elected to decrease the dosing to 1 mg/day and also decrease the concentration.They planned to aspirate the pump segment that was existing and disconnect from the pump.They then would take the old drug out of the pump and fill it with the new lower concentration and perform a back table prime of 0.3 ml over 19 minutes.They would then access the catheter access port and aspirate the pump and spinal segment to confirm catheter patency once the revision was complete.No further issues were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2013, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).The cause of the occlusion was determined to be the catheter migrating caudally.The old catheter was ligated since there was resistance on light pulling.A new catheter was implanted with the tip at t8.No further issues were reported or anticipated.

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: 7569115
• MDR Text Key: 110069498
• Report Number: 3004209178-2018-12575
• 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: company representative,health
• Reporter Occupation: Physician
• 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: 12/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/19/2018; 08/08/2018
• Supplement Dates FDA Received: 07/16/2018; 10/04/2018
• Date Device Manufactured: 06/17/2013
• 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
• Patient Weight: 86