MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 429522

Device Problems Failure to Interrogate (1332); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 01/19/2023

Event Type  Death  

Event Description

After an implantation period of approx.10 months, it was reported that the device was unable to be interrogated in deceased patient.Patient was found collapsed on hospital floor.Resuscitation took place without success.No shocks were delivered during resuscitation.The icd was explanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the icd was visually inspected.Fragments of the leads implanted with the icd were still connected to the header, as illustrated below in figure 1 (left).The connections between the leads and the device were tested, proving that the leads were connected properly.In a next step the leads were visually inspected.An arc-over mark was found on the svc conductor cable of the rv high voltage lead.The leads were subsequently disconnected from the icd and the device was subjected to an electrical analysis.As mentioned in the complaint, the device could not be interrogated.Therefore, the icd was opened and the inner assembly was inspected.The analysis of the electrical module revealed that the output stages of the high voltage circuit had been damaged.This damage indicates a shock delivery into an external short circuit, which is consistent with the arc-over mark on the svc conductor cable of the rv lead.Due to this damage of the electrical module, the device could not be interrogated properly.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.Based on these findings, the device damage occurred during or after the explantation of the system while the shock path was temporarily shorted.If the therapy functions of the icd are not deactivated during the explantation, the temporarily shorted leads may cause noise, leading to defibrillation shocks into an external short circuit and therefore to the observed damage of the device.In conclusion, the device was damaged due to a shock delivery into an external short circuit.As the device could not be interrogated, no information can be retrieved from the time before the damage occurred.Analysis revealed no indications of a material or manufacturing problem.

• Brand Name: ACTICOR 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16263740
• MDR Text Key: 308360639
• Report Number: 1028232-2023-00420
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 429522
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death