MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE RECHARGEABLE BATTERY

Model Number 102515

Device Problems Pumping Stopped (1503); Use of Device Problem (1670)

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

Event Date 05/17/2014

Event Type  malfunction  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported by the physician that the patient went to the emergency room due to a message "clock not set" displayed on his system controller.The patient stated that he fell asleep the night before a approximately 11:00pm and did not wake up until 1:00pm the next day.When the patient woke up, he stated that the batteries were dead and the pump was "off".He exchanged the batteries and the pump started.When interrogating the history, the physician saw "low voltage" advisories starting at 4:02am.The patient was asymptomatic.The physician was instructed on resyncing the date/time to the system controller and the alarm cleared.It was also suggested by the clinical consultant that a heparin gtts be started due to the undetermined amount of time the pump may have been off.

Manufacturer Narrative

The manufacturer is attempting to acquire the device for further evaluation.No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

• Brand Name: HEARTMATE RECHARGEABLE BATTERY
• Type of Device: RECHARGEABLE BATTERY
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORP.; 6035 stoneridge dr.; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3950795
• MDR Text Key: 4644605
• Report Number: 2916596-2014-00993
• Device Sequence Number: 1
• Product Code: MOY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102515
• Device Catalogue Number: 102515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2014
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 05/17/2014
• Date Manufacturer Received: 05/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 103