MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	D334TRM
Medical Device Problem Code	Battery Problem: High Impedance (2947)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and analyzed.Analysis of the device found high internal battery resistance.Hybrid analysis confirmed the charge circuit timeout using the original device battery.No significant leakage was observed on the high voltage therapy capacitors and the hybrid charged nominally when the battery was replaced with an external supply.The results were consistent with the device battery causing the charge circuit timeout and excessive charge time.Battery analysis revealed no internal battery shorting.Lithium-severing and partial lithium-severing was observed.The excessive charge times resulted from an increased battery resistance induced by lithium-severing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The cardiac resynchronization therapy defibrillator (crt-d) was replaced due to reaching normal battery depletion.The device was returned to the manufacturer, analyzed and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: PROTECTA CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7092431
• Report Number: 3004209178-2017-25254
• Device Sequence Number: 11107276
• Product Code: NIK
• UDI-Device Identifier: 00613994714619
• UDI-Public: 00613994714619
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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 Expiration Date: 07/14/2013
• Device Model Number: D334TRM
• Device Catalogue Number: D334TRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR