MAUDE Adverse Event Report: MEDTRONIC INC. / HEARTWARE, INC. MEDTRONIC HEART WARE; VENTRICULAR (ASSIST) BYPASS

Device Problems Circuit Failure (1089); Defective Component (2292); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Per medtronic summary provided to center, of the 5 batteries sent for review, 4 had identified concerns.One battery was incorrectly reading total capacity (b)(4).Two batteries (b)(4) demonstrated internal circuit failure causing no power output to the controller or an ability to charge when connected to battery charger.The final battery (b)(4) demonstrated a solder defect which causes no power output to the controller or ability to charge when connected to the battery charger.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC HEART WARE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC INC. / HEARTWARE, INC.
• MDR Report Key: 14311807
• MDR Text Key: 291229458
• Report Number: MW5109565
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White