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

Model Number 8637-20

Device Problems Nonstandard Device (1420); Pumping Stopped (1503); Mechanical Jam (2983)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer¿s device registration system indicates that the pump was replaced on (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a company representative regarding a patient receiving dilaudid (10 mg/ml at 2.660 mg/day) and clonidine (217 mcg/ml at 57.72 mcg/day) via an implanted pump.The indication for pump use was other chronic/intractable pain (trunk/limbs) and spinal pain.It was reported that on the morning of (b)(6) 2018 the patient was seeing the 8476 (motor stall) code on her ptm (personal therapy manager) and the pump was alarming.Per the reporter, they were hearing ¿the multiple alarms going off and its going like every 5 minutes".The alarm sounded like a beeping european ambulance.The patient had a stimulator implanted 4 months ago, but it was in her back and the pump was in her front and she had not missed a pump refill.The next refill was due (b)(6) 2018.The patient was not having signs of withdrawal, but she was ¿not getting any pain relief whatsoever, her pain was at a 9 or 10¿ which had also started today ((b)(6) 2018).Additional information was received later the same day from a company representative who reported that the pump motor was stalled.There were no environmental, external, or patient factors that may have led or contributed to the issue.No diagnostics and/or troubleshooting had been performed.Pump replacement was scheduled for (b)(6) 2018.The issue was not resolved at the time of the report.The patient status was reported as ¿alive ¿ no injury¿.It was indicated that the healthcare professional did not have any further information regarding the event.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pump was returned and analysis found gear train anomaly; corrosion and-or wear and-or lubrication.The stall was due to shaft-bearing.Method, results and conclusion codes have been updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• 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: 7689780
• MDR Text Key: 114037253
• Report Number: 3004209178-2018-15794
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,consum
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR