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

Model Number 429532

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

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that the device shows the eos status.The icd was replaced.No adverse patient events were reported.Should additional information be received, this file will be update.

Manufacturer Narrative

Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The device interrogation revealed the eos battery status, detected on october 16, 2023.The device was implanted for 46 months and 8 charging cycles were recorded in the devices memory.Next, the current consumption of the icd was analyzed and found to be normal and as expected.However, an inconsistency between current consumption and battery voltage was noted.Therefore, the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage showed a depleted battery.The current consumption of the electronic module was verified by direct measurement and proved to be as expected.There was no indication of a malfunction of the electronic module.The battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated with this battery.The visual inspection of the battery did not reveal any external signs of damage.The voltage measurement confirmed the battery depletion.At a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified damaged insulation, which led to an increased internal self-depletion within the battery and therefore contributed to the clinical observation.In conclusion, the analysis revealed an elevated internal self-depletion within the battery to be the root cause of the clinical observation.

• Brand Name: RIVACOR 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: 18029255
• MDR Text Key: 326848277
• Report Number: 1028232-2023-05490
• Device Sequence Number: 1
• Product Code: NIK
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2023

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: 07/31/2021
• Device Model Number: 429532
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 10/30/2023
• Date Device Manufactured: 07/03/2019
• 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