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 Codes	Premature Discharge of Battery (1057); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6947m62, lead, implanted (b)(6) 2012.Product event summary: the device was returned for analysis.Performance data collected from the device was received and analyzed.Analysis of the device memory indicated charge circuit inactive.Analysis of the device memory indicated an alert for excessive charge time eos (end of service).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient¿s cardiac resynchronization therapy defibrillator (crt-d) had a charge circuit inactive alert and the device indicated end of service (eos) prematurely.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 incurred a charge time out with the original device battery.The device provided nominal 35 joule charges times when using an external supply.A battery depletion mechanism such as high current drain was not observed.The hybrid analysis results were consistent with the device battery causing the device to charge inefficiently.No hybrid anomalies were found.Battery destructive analysis revealed no internal battery shorting.Lithium-severing was observed, leading to reduced anode surface area.Review of the save-to-disk data found excessive charge time events and charge time-outs before the recommended replacement time and subsequent explant.The charge timeout and 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: 6779761
• Report Number: 3004209178-2017-16634
• Device Sequence Number: 220254
• Product Code: NIK
• UDI-Device Identifier: 00613994714619
• UDI-Public: 00613994714619
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 08/14/2013
• 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: 06/09/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR