MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 5 DR-T DF-1; ICD

Model Number	383566
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Syncope/Fainting (4411)
Date of Event	10/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was admitted to the hospital on (b)(6) 2020 after losing consciousness.External cardioversion was attempted and patient recovered.After patient was stabilized, device interrogation was attempted, but the device could not be interrogated.Homemonitoring data showed the device was approximately 30 percent before event, so it was assumed that the battery was depleted.On (b)(6) 2020 the device was explanted and replaced.
Additional Manufacturer Narrative
The icd was subjected to an electrical analysis, revealing that the device could not be interrogated, confirming the clinical observation.Therefore, the icd was opened and the inner assembly was inspected.During the inspection of the electronic module, the analysis revealed that the fuse separating the battery from the electronic module had blown and the output stages of the high voltage circuit had been damaged.Due to this damage of the electronic module, the device could not be interrogated properly.Based on the symptoms, the device was damaged due to a shock delivery of the icd into an external short circuit.Possible clinical complications that might lead to an external short circuit include but are not limited to twiddler syndrome, subclavian crush syndrome or other lead insulation damages.In addition 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.In conclusion, the electronic module was found damaged due to a shock delivery into an external short circuit.Due to the damages the device could not be interrogated properly.The analysis revealed no indication of a material or manufacturing problem.
Additional Manufacturer Narrative
Update received 30-nov-2022: (b)(6) 2021, the patient passed away due to non ischemic intestinal necrosis from cardiovascular failure.The doctor commented that the patient death and the event are not related.The icd was subjected to an electrical analysis, revealing that the device could not be interrogated, confirming the clinical observation.Therefore, the icd was opened and the inner assembly was inspected.During the inspection of the electronic module, the analysis revealed that the fuse separating the battery from the electronic module had blown and the output stages of the high voltage circuit had been damaged.Due to this damage of the electronic module, the device could not be interrogated properly.Based on the symptoms, the device was damaged due to a shock delivery of the icd into an external short circuit.Possible clinical complications that might lead to an external short circuit include - but are not limited to - a twiddler syndrome, a subclavian crush syndrome or other lead insulation damages.In addition 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.In conclusion, the electronic module was found damaged due to a shock delivery into an external short circuit.Due to the damages the device could not be interrogated properly.The analysis revealed no indication of a material or manufacturing problem.

• Brand Name: ILESTO 5 DR-T DF-1
• 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: 11156909
• Report Number: 1028232-2021-00225
• Device Sequence Number: 14422527
• Product Code: MRM
• UDI-Device Identifier: 04035479125226
• UDI-Public: 04035479125226
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 383566
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 11/30/2022
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 08/02/2021; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown