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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient receiving 24 mg/ml of dilaudid, 6 mg/ml of ropivacaine, and 1000 mcg/ml of baclofen at 6.934 mg/day, 1.7334 mg/day, and 288 mcg/day, respectively, via an implantable pump for spinal pain.It was reported the patient¿s pump was replaced on (b)(6) 2018 and the device was discarded by the customer.At the time of the replacement, the doctor reported that he was replacing the pump because the pump was inaccurate due to the patient letting his pump run empty for a long time.The doctor stated the pump was no longer working.It was reported they did not know when this event happened and could not estimate a time frame.It was reported the issue had been resolved at the time the report.The patient¿s status at the time of the report was provided as ¿alive - no injury.¿ no further complications were reported or anticipated.Other medications being taken by the patient at the time of the event, patient weight, and medical history were unknown.

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 (b)(6) 2018.It was not known why the patient let their pump run empty.It was also unknown if the patient experienced any symptoms.It was clarified that the pump no longer being accurate meant that there was a volume discrepancy issue, there was too much volume in the pump.It was confirmed this is what the doctor was referring to when he reported the pump was no longer working.It was unknown if any troubleshooting had been performed related to the report that the pump was inaccurate and no longer working.Regarding the cause of the pump no longer working, no other issues were 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: 7557912
• MDR Text Key: 109694415
• Report Number: 3004209178-2018-12279
• 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
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• 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: 05/31/2018
• Date Device Manufactured: 07/12/2013
• 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 Age: 44 YR