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

Model Number 8637-40

Device Problem Aspiration Issue (2883)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products product id: 8703w, serial# (b)(4), implanted: (b)(6) 1999, product type: catheter.Other relevant device(s) are: product id: 8703w, 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's representative (rep) regarding a patient who was receiving 2000mcg/ml compounded baclofen at 700.4mcg/day and 2mg/ml dilaudid at 0.7004mg/day via an implantable infusion pump for an unknown indication for use.The patient's pump was being replaced due to end of life.The patient reported that they had not noticed any signs of withdrawal.The patient reported that there had not been any increases had been made to the pump in the last couple months.The catheter would not aspirate and the doctor did not want to replace the catheter.The doctor stated it had been working and the patient hadn't experienced any withdrawal symptoms.It was suggested to the doctor to replace the catheter, but the doctor refused stating that it was working before.The catheter was not replaced and no bolus was given per the doctor's request.It was reported that the issue was resolved at the time of the report.The doctor did not plan on doing anything else at the time for the patient.The doctor stated sometimes the old catheter wouldn't aspirate.The patient's status at the time of the report was noted as " alive-no injury." no further complications were anticipated/reported.

Manufacturer Narrative

Concomitant medical products: product id: 8703w, serial#: (b)(4), implanted: (b)(4) 1999, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp).It was reported that the cause of the inability to aspirate was the collapse of the tubing.It was reported the pump was functioning well and providing relief of pain and spasms.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: 7495663
• MDR Text Key: 107751905
• Report Number: 3004209178-2018-10381
• 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
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• Date Device Manufactured: 08/10/2011
• 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 Age: 65 YR