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

Model Number 8637-20

Device Problems Unstable (1667); Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problems Host-Tissue Reaction (1297); No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 8709sc, lot# n281259013 serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type catheter.Fdc code applies to pump 8637-20, s/n:(b)(4).Fdc code applies to catheter 8709sc, s/n:(b)(4).

Event Description

Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving baclofen, 2000 mcg/ml concentration at 400 mcg/day dose via intrathecal drug delivery pump for intractable spasticity and other spasticity.It was reported that the hcp tried to aspirate catheter during routine (end of service) eos pump replacement, and was unable to aspirate.For environmental/external/patient factors that may have led or contributed to the issue, patient reported that her pump kept flipping.For diagnostics/troubleshooting performed, there were no prior diagnostics performed.It was just the catheter aspiration during the procedure.The hcp replaced pump segment of catheter.Partial explant was done on catheter and the hcp removed 7.5 cm pigtail pump portion as well as 1.5 cm of spinal portion and replaced with sutureless connector, 7.5 cm.It was unable to determine the return status of the catheter and the hospital had possession of the explanted catheter.At the time of the report, the issue was resolved and patient status was alive- no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received on 07-mar-2018 and it was reported that when the hcp (healthcare professional) opened the pocket for the pump replacement, there was a ¿whitish toothpaste like material¿ around the pump and the connection to the catheter and some other random places.The hcp sent it for culture and it came back negative.No further complications were reported/anticipated.

Manufacturer Narrative

Device code (b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the hcp reported the cause of the pump flip was that the sutures holding the pump to the fascia were broken.The hcp stated there were no observed kinks, damage, or twist to the catheter.The hcp stated since the procedure was an end of service routine replacement, they did not feel it was necessary to return the pump to the manufacturer.The pump was discarded as per operating room protocol.The hcp stated the replacement occurred just before eos had reached.

• 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: 7204192
• MDR Text Key: 97706673
• Report Number: 3004209178-2018-00979
• 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
• Report Date: 03/08/2018

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: 08/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 03/07/2018
• Supplement Dates FDA Received: 01/31/2018; 03/08/2018
• Date Device Manufactured: 03/01/2011
• 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: 53 YR