MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 7 DR-T DF-1; ICD

Model Number	390064
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore only based on the inspection of the returned device data.The returned device data have been inspected.During the inspection, the battery status eri could be confirmed because of an unexpectedly low battery voltage.This inconsistency of battery voltage and current consumption was detected leading to the activation of the eri status.In order to exclude any potential harm for the patient we therefore would like to recommend to replace the device and to return it for analysis to biotronik.Of course, individual circumstances and medical judgment determine decisions about patient care.The above recommendation is based on a purely technical assessment.Should additional relevant information or the device itself become available, the investigation will be updated.
Event or Problem Description
Device had 60 percent remaining in (b)(6) but read eri on (b)(6) 2019.The device remains implanted, but a change out is being scheduled.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
This device was explanted and replaced.Upon receipt, the interrogation of the implantable cardioverter defibrillator revealed the device status eos which was detected by the device after the explant on (b)(6) 2019.The device history record was inspected, documenting that the device performed as expected during the device manufacturing.The icd was subjected to an electrical analysis.Therefore the eos status was removed 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 delivered a defibrillation shock.However, the specified energy level was not reached.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 electronic module was attached to an external power supply to test the functionality of the module.Thereby, the electrical parameters, particularly the current consumption of the electronic module were found to be normal and as expected.The ability of the electronic module 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.In particular, the specified energy level was reached.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 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, premature battery depletion was confirmed by analysis.Bench testing on the device was performed, and no sources of high current were noted.The electronic module worked as expected with an external power supply.The premature battery depletion was caused by insulation damage within the battery.

• Brand Name: IFORIA 7 DR-T DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8465351
• Report Number: 1028232-2019-01291
• Device Sequence Number: 1341514
• Product Code: MRM
• UDI-Device Identifier: 04035479126926
• UDI-Public: 4035479126926
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: 390064
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 04/05/2020
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR