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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Shelf Life Exceeded (1567)

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

Event Date 07/19/2017

Event Type  Injury  

Event Description

Information was received from a foreign healthcare provider (hcp) regarding a patient who received fentanyl (2000mcg/ml, 1430mcg/day) and bupivacaine (2.5mg/ml, 1.79mg/day) in an implantable pump for an unknown indication for use.A motor stall was seen during initial interrogation.The patient did not recently have an mri.The pump event logs confirmed a motor stall occurred on (b)(6) 2017 with no associated electromagnetic interference (emi).The pump was currently beeping and the hcp wanted to program the pump to off state.The pump was not going to be replaced for a couple weeks.Technical services provided the pump off password (for the next day, (b)(6) 2017).It was recommended for the hcp to return the pump to the manufacturer if explanted/replaced.There were no patient symptoms reported.No further complications were reported/anticipated.

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.

Event Description

Additional information received from a foreign healthcare provider (hcp) via a manufacturer representative indicated the patient experienced opiate withdrawal.The pump was not scheduled to be replaced at this time.The patient was unsure if they wanted the pump replaced.The pump would be returned if explanted.No further information was available.

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign health care provider (hcp) via a manufacturer representative indicated the pump was replaced on (b)(6) 2017.As of (b)(6) 2018, the issue was considered resolved.The status of the patient was stated to be alive and with no injury.The pump would be returned.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative (rep) and confirmed explant was on (b)(6)2017.It was noted the device had not been returned as of now.This was being held due to internal hospital issue.The tracking will be provided when available.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Analysis of the pump revealed pump motor gear train anomalies.These included corrosion and/or wear and/or lubrication and stall due to shaft-bearing.Device code (b)(4) does not apply.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: 6751505
• MDR Text Key: 81358940
• Report Number: 3004209178-2017-15824
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2012
• 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