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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

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

Event Date 12/12/2017

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 health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and multiple sclerosis.The pump contained an unknown brand of baclofen with an unknown concentration and dose.It was reported the patient recently had an mri and experienced a motor stall on (b)(6) 2017 that had not recovered as of the day of report.The representative was going to have the hcp check the logs again to see if a motor stall recovery was noted in the logs.No patient symptoms/complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a company representative.It was unknown if any alarms were heard from the pump.It was unknown what interventions were done to resolve the motor stall.The patient was referred to a surgeon for a replacement consultation.It was unknown if the issue was resolved.The patient¿s weight at the time of the event was unknown.The provided information has been confirmed with the physician.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) did not reveal any anomalies.The returned pump passed all functional testing in the lab.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 250.0 mcg/ml of baclofen at 38.02 mcg/day.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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

No longer applicable to this case.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a device manufacturer representative.The pump's motor stalled on (b)(6) 2017 after an mri, per the pump logs.A tube set message occurred on (b)(6) 2017.During a refill on (b)(6) 2017 the motor stall recovered.The pump was replaced on (b)(6) 2018.The issue was considered resolved at the time of the report.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative indicated a motor stall recovery occurred when the pump was interrogated on (b)(6) 2017.There was no unusual discrepancy observed.It was noted the pump had already been turned down prior to interrogation.It was further stated there was reason to believe the pump was delivering medication following the mri on (b)(6) 2017.However, the health care provider (hcp) was nervous and had the patient referred for replacement.

• 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: 7151700
• MDR Text Key: 96030015
• Report Number: 3004209178-2017-26739
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• 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-0591-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR