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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Human-Device Interface Problem (2949); Mechanical Jam (2983)

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

Event Date 04/10/2018

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 (hcp) regarding a patient who was receiving bupivacaine (2% concentration at 8.051 mg/day) and dilaudid (4mg/ml at 1.6101mg/day) via intrathecal drug delivery pump.The indication for use was noted as non-malignant pain and failed back surgery syndrome.It was reported that a motor stall was seen at initial interrogation.The patient recently had an mri.The motor stall was active.The event date was (b)(6) 2018.No symptoms were reported.There were no further complications reported at this time.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the hcp via a manufacturer¿s representative (rep) on 2018-apr-17.The bupivacaine concentration was also reported as 8.051.It was reported that the patient had a motor stall when working with an engine.The patient stated he was working with a motor/engine that had a magnetic field he was unaware of on (b)(6) 2018 (event date was also reported as (b)(6) 2017, which conflicts with the other information in the event).He heard audible alarms that evening, but stated he didn't know where it was coming from.The patient was seen at the clinic on (b)(6) 2018 and was placed in minimum rate.Troubleshooting consisted of interrogating the pump and reading the logs.The pump was explanted and replaced on (b)(6) 2018.The customer was notified that the pump should be returned to the for analysis, the hospital was in possession of the pump, and it will be returned.The patient weight was provided.The patient status was reported as ¿alive ¿ no injury.¿ the issue was resolved at the time of the report and the hcp would have no further information on the event.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(4) 2018.The device disposition was unknown.The patient reported a motor stall on (b)(6) 2018, which conflicts with the previously reported information.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.No further complications were reported/anticipated.Additional information was received from a healthcare provider via a clinical study on 2018-apr-19.It was reported that the event date was (b)(6) 2018 (note: this information conflicts with the previously reported event date(s).

Manufacturer Narrative

Analysis of the pump identified corrosion and/or wear and/or lubrication of the motor gear train, and a stall due to shaft bearing.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 12-feb-2020 from the consumer who reported that the patient "had an incident in the last 2 years where the pump was effected by emi from the machine he was working on" stating emi "stopped his pump".The reporter stated it was "horrible event where he went into withdrawal".No further complications were reported regarding the event.

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
• MDR Report Key: 7426394
• MDR Text Key: 105401572
• Report Number: 3004209178-2018-07910
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/13/2020

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: 04/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 04/20/2018; 11/08/2018; 02/12/2020
• Supplement Dates FDA Received: 04/18/2018; 04/25/2018; 11/26/2018; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0592-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 95