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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.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.In particular, the specified energy level was reached.At a next step the memory content of the device was inspected.The inspection revealed that the battery voltage temporarily dropped below the eri-threshold, which led to the automatic detection of the eri battery status.Furthermore, the data showed an inconsistency between the amount of charge taken from the battery and the battery voltage.Therefore, the device was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The overall current consumption of the electronic module was directly measured and proved to be normal and as expected.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 battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis.The visual inspection of the battery did not reveal any external signs of damage.The microcalorimetry analysis showed an elevated heat dissipation.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified damaged insulation, which led to an elevated internal self-depletion.In conclusion, the device was implanted for 53 months.The analysis revealed an elevated internal self-depletion within the battery.Based on the analysis all therapy functions of the device were entirely available while the device was implanted and in service.
Event or Problem Description
It was reported on (b)(6) 2019 that this device had 63 percent battery in april and is now eri.No settings or programming changes that could have contributed to the eri status.The device is only pacing very infrequently, does not seem to be drawing from the battery frequently.Patient reported that device feels funny, possibly the pocket is too large and device is migrating.Device was explanted and replaced.

• Brand Name: IFORIA 7 DR-T DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 10623748
• Report Number: 1028232-2020-04152
• Device Sequence Number: 2604041
• Product Code: MRM
• UDI-Device Identifier: 04035479126926
• UDI-Public: 04035479126926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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 Expiration Date: 08/31/2017
• Device Model Number: 390064
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR