MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 VR-T DX; ICD

Model Number	372419
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Twiddlers Syndrome (2114)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
System explanted due to dislodgement caused by twiddler syndrome.Should additional information become available, this file will be updated.
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.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status mol1.The icd was implanted for 76 months and 55 charging cycles were recorded to the device memory.The memory content of the device was analyzed.During the analysis of the available iegms, noise was observed in the atrial and ventricular channels.The ability of the device to deliver therapies was verified.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 conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of an icd malfunction.

• Brand Name: LUMAX 740 VR-T DX
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10387144
• Report Number: 1028232-2020-03323
• Device Sequence Number: 3446875
• Product Code: LWS
• UDI-Device Identifier: 04035479116057
• UDI-Public: 04035479116057
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2020

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: 372419
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 02/01/2021
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/24/2020; 02/03/2021
• 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: 51 YR