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	Delayed Charge Time (2586)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6935m lead, implanted (b)(6) 2014.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) reached end of service (eos) due to long charge time.The device was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device found high internal battery resistance.Hybrid analysis confirmed that the device did not charge efficiently by observing excessive charge time.The device charged nominally when the battery was replaced with an external supply.No significant leakage was observed on the high voltage therapy capacitors.No hybrid anomalies were found.The results were consistent with the device battery causing the longer charge times.Battery analysis revealed no internal battery shorting.Lithium-severing and partial lithium-severing was observed.Review of the device data showed an excessive charge time event prior to recommended replacement time and subsequent explant.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.

• 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: 6782517
• Report Number: 3004209178-2017-16982
• Device Sequence Number: 220897
• Product Code: NIK
• UDI-Device Identifier: 00613994714619
• UDI-Public: 00613994714619
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2013
• Device Model Number: D334TRM
• Device Catalogue Number: D334TRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 11/04/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR