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 09/28/2022

Event Type  malfunction  

Event Description

It was reported that the device showed eos status after the patient was having a shoulder surgery.A magnet was applied on the icd.No adverse patient events were reported.The device remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

17-oct-2022 we were informed that this device was explanted.-.

Manufacturer Narrative

(b)(6) 2022 we were informed that this device was explanted.-upon receipt, the icd was interrogated, revealing the eos battery status.The icd was implanted for five months and 91 charging cycles were recorded in the devices memory.The memory content of the device was analyzed.During analysis of the available iegms noise was observed in the right ventricular channel of episode 93, leading to one charging cycle.This charging cycle was aborted due to the activation of the eos battery status on (b)(6) 2022 at 10:01 h.At a next step, the icd was subjected to an electrical analysis.Therefore, the eos status was removed with a technical programmer and subsequent interrogation revealed the bos battery status.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 normal and expected sensing and shock delivery.There was no indication of a device malfunction.Based on the analysis, it is likely that the magnet applied during the shoulder surgery had an unfavorable position during the episode prior to eos detection on (b)(6) 2022.An unfavorable orientation in combination with 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 during an ongoing charging, 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 device 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.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.There was no indication of 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: 15584901
• MDR Text Key: 301674989
• Report Number: 1028232-2022-05224
• 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,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• 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: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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): Hospitalization