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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Intermittent Infusion (2341)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/22/2018

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 via the manufacturing representative (rep) regarding a patient receiving an unknown dose and concentration of an unknown drug via an implantable pump for non-malignant pain and lumbar radiculopathy.It was reported the patient¿s pump was alarming.The pump was interrogated, and the logs showed a series of motor stalls and recover ies had occurred.A motor stall occurred on (b)(6) 2018 at 07:59 and recovered later that day at 22:42, a motor stall occurred on (b)(6) 2018 and recovered on (b)(6) 2018, a motor stall occurred on (b)(6) 2018 and recovered on (b)(6) 2018 at 00:50, and a motor stall occurred on (b)(6) 2018 at 13:38 and recovered on (b)(6) 2018.The healthcare provider was advised to place the pump to minimum rate to avoid any potential overdose, and to schedule a time to replace the pump.It was reported the patient experienced withdrawal symptoms over the days consistent with the motor stall events in the pump logs.The pump was 7 months from the elective replacement indicator (eri).Regarding environmental/external/patient factors that may have led or contributed to the issue, the patient did say he fell prior to the motor stalls and did hit the pump during the fall.Regarding diagnostics/troubleshooting performed, the logs were read, and the pump was programmed to minimum rate mode.It was indicated a pump replacement was planned.However, the replacement had not been scheduled yet at the time of the report.It was reported the issue was resolved at the time of the report.The patient¿s status was provided as ¿alive - no injury.¿ no further complications were reported or anticipated.Other medications being taken at the time of the event, medical history, and patient weight were unknown.

Manufacturer Narrative

The device code and evaluation codes have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep) 2018-jul-10.The rep reported they sent the pump in to the manufacturer for analysis.No other actions or interventions have been taken.The cause of the motor stalls has not been determined.

Manufacturer Narrative

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.

Manufacturer Narrative

Interrogation of the device revealed the pump had been programmed to deliver 15.0 mg/ml of morphine.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The evaluation codes have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

The pump was returned to the manufacturer for analysis.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) revealed residue in the motor gear train and wearing on the upper shaft of gear number two.Analysis also identified that the pump exceeded the dispense accuracy specification by dispensing more fluid than the programmed rate during dispense testing in the lab.The cause of the overinfusion was not determined.The evaluation codes have been updated.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: 7655597
• MDR Text Key: 112932663
• Report Number: 3004209178-2018-14798
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2012
• 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: 63 YR