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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Battery Problem (2885)

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

Event Date 05/05/2018

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 receiving intrathecal gablofen 2000 mcg/ml at 1567.6 mcg/day via an implanted pump for intractable spasticity and head/brain injury.An alarm was heard and telemetry was not yet performed.The patient was in the emergency room (er) reporting a critical alarm.The reporter wanted to know if this pump was part of the battery performance field action and it was confirmed it was not included in this population.It was recommended to interrogate the pump and possibly contact a manufacturer representative (rep) for assistance.Patient symptoms were not reported.The event date was (b)(6) 2018.No further complications were reported/anticipated or expected.Additional information was received from a healthcare provider (hcp) via a manufacturer representative.It was reported that the pump had a premature motor stall.Elective replacement indicator was in 12 months from (b)(6) 2018.It was reported that the critical alarm started going off on (b)(6) 2018, which conflicted with the previous report.No environmental, external, or patient factors were reported to have caused this issue.When reading the logs, it showed that a motor stall occurred.The pump was replaced with a 40cc pump.The issue was said to have been resolved and the patient was "alive- no injury." there were no further complications reported at this time.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.The returned pump was interrogated and as per the logs the following medications were being administered via a simple continuous dose rate as of (b)(6) 2018: gablofen with concentration 2,000 mcg/ml at a dose rate of 12.7 mcg/day.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative (rep) via the return paperwork for the pump.It was reported the patient was receiving lioresal 2,000 mcg/ml at 1,568.9 mcg/day.The pump was replaced on (b)(6) 2018.The critical alarm started going off on (b)(6) 2018 and the patient went to the er.The logs showed a motor stall occurred and the pump was replaced.It was noted there was no patient injury and the patient¿s status after the device was removed was ¿recovered without sequela.¿ it was further reported the battery was depleted and the patient had a sudden loss of therapy.A rotor study and dye study were not performed.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer indicated they had changed the doctor since the pump quit working so they had to replace the old pump.No other information was provided.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Analysis revealed pump motor and gear train anomalies related to corrosion and/or wear and/or lubrication, and stall due to shaf t-bearing.(b)(4).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: 7500320
• MDR Text Key: 107783985
• Report Number: 3004209178-2018-10496
• Device Sequence Number: 1
• Product Code: LKK
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2012
• 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
• Patient Age: 29 YR