MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 595000-001

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem Dizziness (2194)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

The customer reported that the patient's wife reported last week that she heard a strange noise, loose parts inside, coming from the driver while supporting the patient at home.The customer advised the patient's wife that the driver needed to come back in for exchange urgently for safety reasons.The customer also reported that the patient's wife refused to return the driver to the clinic.The customer also reported that yesterday the patient's wife reported that the patient coughed and then the driver suddenly stopped for some seconds.The patient felt dizzy and then the driver started again but gave a continuous alarm.The customer also reported that the patient felt better and his wife switched to the backup driver without any issue and afterwards the patient was transferred to (b)(6) hospital for evaluation.

Manufacturer Narrative

The customer also reported that the patient is fine and there was no permanent impact to his health.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq. ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4898725
• MDR Text Key: 6021040
• Report Number: 3003761017-2015-00211
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR