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

Model Number	429522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to unexpected battery behavior.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned data.The manufacturing process for this icd was reviewed.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned data has been analyzed.The data documents three shock abortions on december 27th, 2025, due to three different reasons.The first shock was aborted due to vf termination.Afterward, a new shock charging was aborted due to lead shock impedance measurement out of range (less than 20 ohms).The third and last shock charging was aborted due to an icd reset.The abortion leads to episode termination, thus the iegms cannot be recovered.The above observations are indicative for a short circuit in the high voltage lead channel, which presumably led to a damage of the icd.In conclusion, the icd was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned data indicates a potential damage of the rv lead, which presumably led to an icd damage.Should the devices become available for analysis, this report will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was visually inspected.The inspection revealed abrasion marks as well as a spot of molten titanium on the icd housing.The icd was subjected to an electrical analysis, revealing 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 - a twiddler syndrome, a subclavian crush syndrome or other lead insulation damages.The available data has been analyzed.The data documents three shock abortions on december 27, 2025, due to three different reasons.The first shock was aborted due to vf termination.Afterwards, another shock charging was aborted due to lead shock impedance measurement out of range (less than 20 ohms).The third and last shock charging was aborted due to an icd reset.The abortion leads to episode termination, thus the iegms cannot be recovered.The manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.Biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.

• Brand Name: ACTICOR 7 HF-T QP DF4 IS4 PROMRI
• Common Device Name: 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: 23974185
• Report Number: 1028232-2026-00053
• Device Sequence Number: 17300770
• Product Code: NIK
• UDI-Device Identifier: 04035479156671
• UDI-Public: (01)04035479156671(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 429522
• Device Catalogue Number: 429522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 01/08/2026; 03/02/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/08/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: 68 YR
• Patient Sex: Female