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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

Info references the main component of the system and other applicable components are: product id neu_unknown_cath, partially explanted: (b)(6) 2018 product type catheter (b)(6).(b)(4).Conclusion code applies to both pump and catheter.

Event Description

Information was received from a health care professional (hcp) via a representative regarding a patient in portugal who received lioresal 2000 ug/ml at a dose of 1018.8 ug/day via an implantable pump.The patient¿s medical history included cerebral palsy.The physician described that during device follow-ups on three occasions, on (b)(6) 2017, the pump reservoir was empty before the expected date.Although the software stated that it still had enough drug in the reservoir.In regards to contributing factors or causes it was reported that in this hospital the physicians do not use huber needles for the refiling and the physicians are the same.Diagnostic testing and troubleshooting included report that the doctors used different strategies to ensure the drug was in the reservoir, like aspirating the drug right after inserting it in the reservoir to ensure that the drug was in the reservoir and not in the pump pocket.Actions/interventions taken revealed that while in the or it was possible to check the pump silicon septum.It was noted that the septum was a bit damage, especially near the metal silicon interface on the border.Further, the catheter pump segment was partially occluded during the replacement of the pump.When disconnected the catheter was not leaking the usual amount of csf.Although a caveat could be present for that lack of pressure in the catheter.The patient had a severe scoliosis and was lying on their back, although their hips were a tilted to their left.The doctors opted to replace the pump segment.After, the doctor was able to clean the catheter with an abocat injecting saline in it, a white clot was kicked from that catheter segment, the doctor stated that the clot was similar to the ones often found inside the cerebral shunts.It was not possible to retrieve that catheter segment (for return).Patient symptoms were not reported.The pump was replaced on (b)(6) 2018 which was 5 months before the estimated replacement indicator (eri).At the time of the report the issue was reported as resolved and the patient¿s status was reported as alive-no injury.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

It was further clarified that the previously reported ¿review in out 2015¿ meant that the catheter was checked if it was patent and working correctly during a surgery in (b)(4)2015 and so it was working correctly.Clarification was requested regarding the surgery that occurred in (b)(4) 2015 and if this was related to the implanted pump system.

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot#:unknown, ubd:unknown, udi#:asku.If information is provided in the future, a supplemental report will be issued.

Event Description

The following information that was previously captured in this event as noted below, no longer pertains to this current event nor to the manufacturer report #3004209178-2018-01714: information previously reported indicated that the catheter implanted on (b)(6) 2011 was ¿review in out 2015¿.This information was clarified by the representative and health care professional that the ¿review in out 2015¿ meant that the catheter was checked if it was patent and working correctly during a surgery in (b)(6) of the year 2015 and so it was working correctly.Additional clarifying information was provided which indicated that that this was a separate resolved event (from (b)(6) 2015) rather than related to this current event (catheter revision 2018), manufacturer report # 3004209178-2018-01714.Therefore, going forward the information pertaining to ¿review in out 2015¿, a system exploratory/revision in (b)(6) 2015, will be captured in manufacturer report # 3004209178-2018-05592.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) lot# unknown serial# implanted: (b)(6) 2011 partially explanted: (b)(6) 2018 product type catheter pump interrogation revealed the pump infused baclofen 2000 mcg/ml at minimum rate of 12.1 mcg/day.Only the pump was returned for analysis.Visual inspection identified significant damage to the reservoir septum while implanted.However, this damage did not result in a leak during bench testing in the laboratory.The pump also passed dispense accuracy testing.Conclusion code (b)(4) no longer applies to the pump.Patient code (b)(6) no longer applies to this event.Patient codes (b)(6) and (b)(6) apply to both pump and catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the catheter was an (b)(4) but the serial number was not possible to obtain.The catheter was implanted on (b)(6) 2011 and was ¿review in out 2015¿.This information was being clarified.As a result of this event, the patient experienced symptoms of withdrawal, like increased spasticity.It was not possible to have the exact volumes from the refills on (b)(4) 2017 ,(b)(4) 2017 and (b)(4) 2017.However, the physician report that it was empty some good days before the date.On these three dates,(b)(4)2017, (b)(4) 2017 and (b)(4) 2017, the pump was refilled to full capacity of 20 ml.

• 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: 7230039
• MDR Text Key: 98630110
• Report Number: 3004209178-2018-01714
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2018

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: 11/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 01/31/2018; 03/01/2018; 03/16/2018
• Supplement Dates FDA Received: 02/26/2018; 03/06/2018; 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2011
• 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: 18 YR