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

Model Number	365606
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/02/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The icd as well as fragments of the leads were returned and thoroughly analyzed.The leads were still connected to the icd header.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, twiddler syndrome, a subclavian crush syndrome or other lead insulation damages.However, a damage after explantation of the device cannot be excluded based on the results of the lead analysis and the fact that the lead fragments were still connected to the icd header after explant.Upon receipt, the safio s was found cut 10.5 cm distal to the is-1 connector pin.Only the proximal lead fragment was available for analysis.The visual inspection showed a rubbed through insulation 3 cm distal to the is-1 connector pin.Based on the characteristics, it is reasonable to assume that the damage occurred due to interaction with the generator housing.The linox s 65 was found cut 11 cm distal to the is-1 connector pin.Only the proximal lead fragment was available for analysis.The insulation showed signs of abrasion 4 cm distal to the is-1 connector pin which most likely occurred due to interaction with the generator housing.The insulation was however intact in this region.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance tests proved the devices functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacture defect.
Event or Problem Description
It was reported that the patient with this device died suddenly.The icd was removed by the funeral directors using a magnet to inhibit shocks.The leads were cut and the icd was placed in a metal bowl.The device could not be interrogated after the explantation.The device and the associated leads were returned and analyzed.

• Brand Name: LUMAX 740 DR-T
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 12474660
• Report Number: 1028232-2021-05131
• Device Sequence Number: 3349988
• Product Code: MRM
• UDI-Device Identifier: 04035479110253
• UDI-Public: 04035479110253
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: 365606
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/15/2021
• 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: Death