MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 5 HF-T DF4 PROMRI; CRT-D

Model Number 393025

Device Problem Battery Problem (2885)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that the device was explanted due to an unexpected decrease of the remaining battery charge.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 re-investigated.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 eri battery status, 51 charging cycles were recorded in the devices memory.The current consumption of the icd was analyzed and found to be normal and as expected.However, an inconsistency of 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 overall current consumption of the electrical module was directly measured and proved to be normal and as expected.Analysis of the electronic module revealed no indication of a malfunction.Therefore, the battery was disconnected from the electronic module and 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 a depleted battery.In a next step, the battery was opened for destructive analysis.During inspection of the inner assembly a short circuit was identified, which led to an increased internal self-depletion within the battery and therefore to the clinical observation.In conclusion, the battery was found depleted.The electronic module showed no indication of a malfunction.Analysis revealed an increased internal self-depletion within the battery that contributed to the clinical observation.

• Brand Name: IPERIA 5 HF-T DF4 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: 17828496
• MDR Text Key: 324403674
• Report Number: 1028232-2023-04851
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 393025
• 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: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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