MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 VR-T DF-1; ICD

Model Number	383578
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device is not able to be interrogated.The patient showed up to the er after receiving multiple shocks and after that the device was not able to be interrogated.It was recommended to change out the device.Device explanted on (b)(6) 2021.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.
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.

• Brand Name: ILESTO 7 VR-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: 12193524
• Report Number: 1028232-2021-04039
• Device Sequence Number: 11640073
• Product Code: LWS
• UDI-Device Identifier: 04035479125349
• UDI-Public: 04035479125349
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

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 Model Number: 383578
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 12/01/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 07/22/2021; 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2013
• 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 Age: 73 YR
• Patient Sex: Female