MAUDE Adverse Event Report: Thoratec Corporation HEARTMATE® POWER MODULE (N/A); Ventricular (Assist) Bypass

Model Number	1340
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power module, ppm-21599, had a yellow wrench.The alarm was unable to be cleared.The battery was reseated and changed to a new backup battery with no resolution.The power module was planned to be returned for repair.
Additional Manufacturer Narrative
Section a: there was no patient involvement.Section d4: device lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: HEARTMATE® POWER MODULE (N/A)
• Common Device Name: Ventricular (Assist) Bypass
• Manufacturer (Section D): Thoratec Corporation; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): Thoratec Corporation; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50914280
• Report Number: 2916596-2026-2919788
• Device Sequence Number: 5344791
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: (01)00813024010654
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1340
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown