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

Model Number 8637-20

Device Problems Kinked (1339); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 8731, serial# (b)(4), implanted: (b)(6) 2004, product type: catheter; ubd: (b)(6) 2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) regarding a patient receiving 500 mcg/ml of baclofen at 28.58 mcg/day via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported a catheter issue had occurred.The patient was having a routine pump replacement and the catheter ¿wasn't flowing,¿ so the healthcare provider decided to revise the spinal segment.The issue was diagnosed during the revision.Technical services confirmed the new catheter length/volume and confirmed the priming bolus information.No symptoms were reported.It was reported the event occurred on (b)(6) 2018.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep) on may 03, 2018.The rep reported the issue was discovered during the surgery when the patient's pump was being replaced.The rep and the physician discovered the catheter was not flow ing and then went to revise the catheter.The physician went into the spinal segment of the catheter and noticed the catheter was kinked.The physician was not able to get cerebrospinal fluid (csf) back.The physician took out the spinal segment, and when the physician gently tried to pull the catheter back, only half of the catheter came out.The surgical tech measured the segment that was removed, which was roughly 13 centimeters (cms), which indicated half of the catheter was still in the spine.It was reported there was no harm to the patient during this process, and the rep stated the patient was doing fine, to their knowledge.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep) on may 07, 2018.Regarding the broken catheter, the rep thought the catheter broke when the doctor pulled on it, but they could not be sure.The rep confirmed the remaining segment was out of use, and a new segment was implanted.The portion of the catheter that was removed was thrown away by the surgical technician and the rep was unable to return the segment.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider on (b)(6) 2018.The patient's weight was provided as (b)(6) kilograms.

• 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: 7481738
• MDR Text Key: 107187349
• Report Number: 3004209178-2018-09939
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Date Device Manufactured: 10/28/2010
• 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 Age: 75 YR
• Patient Weight: 64