MAUDE Adverse Event Report: THORATEC HEARTMATE II; LVAD

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 01/11/2015

Event Type  Injury  

Event Description

Diagnosis or reason for use: battery clips needed for untethered power support on lvad.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: no.Pt called on-call vad coordinator the evening of (b)(6) 2015 around 9:30 pm.The patient was on batteries and caught one of her controller power cables on something.The "yank" was so forceful, it pulled the controller power lead out along with a piece of the battery clip connector.The piece was on tight and tough to remove or unscrew for the patient and prevented the patient from making a proper connection to another power source with the damaged lead.The vad coordinator informed the patient that she had to come in to the er and have the situation assessed by circulatory support personnel.After assessing the situation, circulatory support determined the pump had not stopped but the patient had to have her controller exchanged due to the damaged lead.The controller exchange was performed successfully and the patient was given a new battery clip to replace the defective one and sent home in good health.

• Brand Name: HEARTMATE II
• Type of Device: LVAD
• Manufacturer (Section D): THORATEC
• MDR Report Key: 4516658
• MDR Text Key: 5492890
• Report Number: MW5040724
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR
• Patient Weight: 100