MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IPERIA 7 DR-T DF4 PROMRI; ICD

Model Number 392423

Device Problems Premature Elective Replacement Indicator (1483); Failure to Transmit Record (1521)

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

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore only based on the returned device data as well as the inspection of the quality documents associated with the manufacture of this particular device.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.The eri battery status was detected on (b)(6) 2020.Further analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.Should further relevant information or the device itself become available this investigation will be updated.

Event Description

On (b)(6) 2020, an alert from hm was observed indicating that the device was unable to receive data.The last date of receiving data was (b)(6) 2020.On (b)(6) 2020, eri alert was received.The voltage was lowered to 2.74v.The doctor contacted to the patient and decided to replace the device.

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 eos battery status, detected on (b)(6) 2020, four days after the device had been explanted.The device was implanted for 56 months and 22 charging cycles were recorded in the devices memory.The icd was subjected to an electrical analysis.First, the eos status was removed with a technical programmer and 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 detected the fibrillation signal as specified.The shock was not delivered, indicating a depleted battery.Subsequently, 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.In a next step, the electronic module was attached to an external power supply to check the functionality of the electronic module.There was no indication of a malfunction.All therapy functions were available and worked as expected.The overall current consumption of the module was directly measured and proved to be normal.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 and the microcalorimetry analysis showed an elevated heat dissipation.At a next step, the battery was opened for destructive analysis and the inner assembly was inspected.The analysis identified a damaged insulation, which led to an increased internal self-depletion and, as a result, to the clinical observation.In conclusion, the battery was found depleted.The therapeutic functionality of the device was tested with an attached external power supply and proved to be fully functional.The analysis revealed an increased internal self-depletion within the battery that contributed to the clinical observation.

• Brand Name: IPERIA 7 DR-T DF4 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10665561
• MDR Text Key: 213479679
• Report Number: 1028232-2020-04376
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 04035479128913
• UDI-Public: 04035479128913
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• 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: 392423
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1