MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 DR-T DF4; ICD

Model Number	383564
Medical Device Problem Codes	Failure to Interrogate (1332); Failure to Convert Rhythm (1540); No Pacing (3268)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Asystole (4442)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in the er after receiving a shock.A field representative interrogated the device at the hospital and determined that no shock had been delivered.The device showed 27 percent battery remaining, but could not be interrogated the following day.Physician decided to explant and replace the device with a competitor icd.On (b)(6) 2021, new information was received from a competitor indicating that the patient had experienced vf and asystole, and the device did not deliver shocks or pacing.Device has not been returned for analysis.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was visually inspected.The inspection revealed a spot of molten titanium on the icd housing.The icd was subjected to an electrical analysis, confirming that the device could not be interrogated.Therefore, based on the observed symptoms, it is reasonable to assume that a shock delivery into an external short circuit led to a damage of the electrical module.Due to the damage of the electrical module the device could not be interrogated, and the memory content of the device was not restorable.Possible clinical complications that might lead to an external short circuit include but are not limited to twiddlers syndrome, subclavian crush syndrome or other lead insulation damages.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the observed damage characteristics.Particularly the final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.

• Brand Name: ILESTO 7 DR-T DF4
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12783331
• Report Number: 1028232-2021-06120
• Device Sequence Number: 3684536
• Product Code: MRM
• UDI-Device Identifier: 04035479125202
• UDI-Public: 04035479125202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Expiration Date: 03/31/2016
• Device Model Number: 383564
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male