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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503)

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

Event Date 05/01/2018

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 a company representative regarding a patient receiving lioresal 2000mcg/ml at 580.3 mcg/day via an implantable pump.The indications for use were intractable spasticity and cerebral palsy.On (b)(6) 2018 the healthcare provider reported that per the managing physician the pump was randomly going into a motor stall.There were no reported environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting performed was reported as the patient continued to go into the managing healthcare physician¿s office for pump maintenance and at times the pump read no further motor stalls so surgical intervention was not scheduled.The managing physician chose to monitor the patient and the patient was exhibiting no symptoms or lack of drug efficacy.Then in late october it was noted that the pump stalled again and the printout displayed eri (elective replacement indicator) notification.The actions and interventions taken to resolve the issue was the pump explanted on (b)(6) 2018 and emptied of the drug remaining in the reservoir which was 18cc¿s and the expected volume was 17-8cc¿s so no volume discrepancy.The existing catheter was checked and csf (cerebral spinal fluid) was obtained through the catheter access port once the new pump was attached to the indwelling catheter.The neurosurgeon suspected the pump exhibited a premature eri (elective replacement indicator) and multiple pump motor stall issue.The issue was resolved at the time of the event and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported or anticipated.

Manufacturer Narrative

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

Additional information was received and per the logs the eri (early replacement indicator) occurred on (b)(6) 2018.The patient recovered without sequela.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis of the pump revealed pump motor feed thru anomaly; shorting across the insulator.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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8114514
• MDR Text Key: 128718707
• Report Number: 3004209178-2018-26459
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2014
• 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-1579-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 57