MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 HF-T DF-1; CRT-D

Model Number	383547
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt, the icd interrogation revealed the battery status eri.The device was implanted for about 53 months and 14 charging cycles were recorded to the device memory.The icd was subjected to an electrical analysis.During the analysis the current consumption of the icd was verified and found to be elevated, confirming the clinical observation.The ability of the device to deliver therapies was tested.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.In a next step, the device was opened to inspect the inner assembly and to check the functionality of the electronic module.Visually, no deficiencies were observed.The current consumption of the electrical module was directly measured.The measurement confirmed an elevated current consumption.Further electrical investigations revealed that a low voltage capacitor of the electronic module was damaged, causing an increased current consumption.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process, which might be related to the clinical observation.Particularly, the final acceptance test proved the device functions to be as specified.In conclusion, the clinical observation resulted from a damaged low voltage capacitor on the electronic module.There was no sign of any inconsistency during the manufacturing process, which might be related to the clinical observation.It is therefore assumed that the damage occurred after the device shipment, however, the date of occurrence was not determinable.Based on the analysis all therapy functions of the icd were available while the device was implanted and in service.
Event or Problem Description
On (b)(6) 2014 - during a follow-up, there was an error reported of elevated power consumption.A reset was performed with no issues all though the battery status continued to drop.The device was explanted and replaced on (b)(6) 2018 due to eri.

• Brand Name: ILESTO 7 HF-T DF-1
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7918766
• Report Number: 1028232-2018-03357
• Device Sequence Number: 1346566
• Product Code: NIK
• UDI-Device Identifier: 04035479125035
• UDI-Public: (01)04035479125035
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2014

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: Health Professional
• Device Model Number: 383547
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/28/2018
• 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
• Patient Age: 69 YR