HEARTMATE RECHARGABLE BATTERIES 2025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-21 for HEARTMATE RECHARGABLE BATTERIES 2025 manufactured by Thoratec Corporation.

Event Text Entries

[17023572] The patient was implanted with a vented electric left ventricular assist device (lvad). It was reported by the lvas supervisor that the pt disconnected the black lead to switch from power base unit to battery support. Subsequently, the white lead was disconnected, and at this time the battery life depleted and the pump stopped within 15-30 seconds. The hospital initially troubleshoot by changing the white lead and the system controller. However, these actions produced the same alarms. Another set of batteries was then used, without further incidents.
Patient Sequence No: 1, Text Type: D, B5


[17231022] The pt remains on lvad support. The batteries were returned to the manufacturer, and are currently being analyzed. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2916596-2006-00130
MDR Report Key752337
Date Received2006-08-21
Date of Report2006-07-21
Date of Event2006-07-21
Date Facility Aware2006-07-21
Report Date2006-07-21
Date Reported to Mfgr2006-07-21
Date Mfgr Received2006-07-21
Date Added to Maude2006-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactROBERT FRYC
Manufacturer Street23 FOURTH AVENUE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7812720139
Manufacturer G1THORATEC CORPORATION
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal Code94588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEARTMATE RECHARGABLE BATTERIES
Generic NameRECHARGABLE BATTERIES
Product CodeMOY
Date Received2006-08-21
Returned To Mfg2006-07-20
Model Number2025
Catalog Number2025
Lot NumberMG104010
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key740127
ManufacturerTHORATEC CORPORATION
Manufacturer Address* PLEASANTON CA * US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-08-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.