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

Model Number 429522

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

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 device data.The memory content of the device was inspected.The inspection of the device data revealed the eos battery status and 45 charging cycles within 13 minute's on (b)(6) 2021 were documented to the devices memory.Charging cycles 34 and 41 were aborted due to magnet application.The last charging cycle was aborted at 8:26h by activation of the eos battery status.An evaluation of the device data after reset showed no indication for a device malfunction.Therefore, it is reasonable to assume that an unfavorable magnet application may have contributed to the clinical observation.An unfavorable orientation as well as a short distance between the magnet and the device during a charging cycle may lead to such rare clinical events.When there is a short distance between the magnet and the icd, and the orientation of the magnet is aligned to cause the magnetic field to be strongest over the high voltage transformer, a saturation of the transformer may appear only during a charging cycle, leading to a temporary drop of the supply voltage below the eos level, resulting in the observed eos battery status.This anomaly does not represent a battery or hybrid malfunction.This status is only achieved with the combination of an exact position of the magnet over the high voltage transformer, and the reduced distance from device to magnet during a charging cycle.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 clinical observation.There was no indication of a material or manufacturing problem.

Event Description

After an implantation period of approx.7 months, it was reported that the device shows the eos status after appropriate shock therapies.Device remains implanted.

• 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 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11729652
• MDR Text Key: 247486378
• Report Number: 1028232-2021-02041
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156671
• UDI-Public: 04035479156671
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 429522
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/26/2021
• Date Device Manufactured: 03/10/2020
• 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