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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Human-Device Interface Problem (2949)

Patient Problem Dyspnea (1816)

Event Date 03/04/2017

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving remodulin (10 mg/ml at an unknown dose) via an implantable infusion pump.It was reported a critical alarm was heard.It was noted they started hearing the alarm intermittently since (b)(6) 2017.The pump was interrogated in the clinic on (b)(6) 2017 and found to be in motor stall.The patient was admitted for replacement and peripheral remodulin.It was further reported the patient noted he heard an alarm intermittently since saturday ((b)(6) 2017) night, and thought it was a toy alarm.On monday he realized it was his pump alarming and called the coordinator.He came to the clinic, the coordinator heard the alarm right away, the pump was interrogated and found to be in a motor stall.The alarm did go off every 10 minutes in the clinic.The patient noted his only symptom was shortness of breath with exertion.He was taken to the emergency room where remodulin was started via a cadd pump through a peripheral intravenous line.The pump was decreased to minimal rate.The patient was then admitted for a pump replacement.The blood tests were all normal for the subject.The site principal investigator determined this to be related to the pump.The event was classified as serious and unanticipated adverse device effect by the investigator.The outcome of the event was reported as unresolved, further actions or treatment planned.

Event Description

Additional information was received from a healthcare provider via a clinical study reporting the patient was admitted to the hospital on (b)(6) 2017 and the pump was explanted 2 days later.A new pump was placed in the same pocket under twilight sedation and was set to minimal rate during the procedure.The patient had blood tests, pump interrogation, and a electrocardiography performed with all normal results.The patient was hospitalized from (b)(6) 2017.It was noted the patient's medications included benadryl iv, cefazolin iv, fentanyl iv, medazolam iv, and vancomycin iv.The patient was taken off external remodulin and the new pump was set to new a delivery dose of 40 ng/kg/min and unknown rate.The patient was discharged home after reviewing alarms on (b)(6) 2017 and the issue was reported to be resolved the same day.No further complications anticipated.

Manufacturer Narrative

Eval code-conclusion no longer applies.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.

Manufacturer Narrative

Analysis of the device found a reliability non-conformance of the pump motor with a gear train anomalies of corrosion and-or wear and-or lubrication and stall due to shaft-bearing.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider (hcp) via a clinical study indicated the patient recovered without sequelae.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6396936
• MDR Text Key: 69653040
• Report Number: 3004209178-2017-05451
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention