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

Model Number	D204TRM
Medical Device Problem Codes	Premature Discharge of Battery (1057); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6947m-62 lead, implanted (b)(6) 2012.Product event summary : performance data collected from the device was analyzed.Analysis of the device memory showed the battery indicator signifying that it the time is approaching for device replacement.Analysis of the device memory indicated high voltage capacitor charge time was longer than expected for a device not yet at eri (elective replacement indicator).The device was returned and analyzed.Analysis of the device found high internal battery resistance.Hybrid analysis confirmed that the device experienced a long charge time indication with the original device battery.The device provided a 35 joule (j) charge within nominal charge time when using an external supply.The device was fully functional and no hybrid anomalies were found.Battery analysis found no internal short.Lithium (li)-severing was observed leading to reduced anode surface area.Review of the save-to-disk data showed an excessive charge time event before recommended replacement time (rrt) and subsequent explant.The excessive charge time resulted from an increased battery resistance induced by li-severing.A voluntary medwatch form 3500 was received (report #mw5070587); since not contained on that form, select fields have been populated by the manufacturer.
Event or Problem Description
It was reported that the device indicated elective replacement (eri), but then suddenly and prematurely indicated 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.

• Brand Name: CONSULTA 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: 6781385
• Report Number: 3004209178-2017-16822
• Device Sequence Number: 1736006
• Product Code: NIK
• UDI-Device Identifier: 00613994714701
• UDI-Public: 00613994714701
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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: 07/14/2013
• Device Model Number: D204TRM
• Device Catalogue Number: D204TRM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 08/09/2017
• 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: 76 YR