MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 7 HF-T QP DF-1 IS4 PROMRI; CRT-D

Model Number	429552
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This device shows unexpected battery behavior several hours after implant.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
It was reported that the device was explanted on (b)(6) 2022.
Additional Manufacturer Narrative
It was reported that the device was explanted on (b)(6) 2022 upon receipt, the device interrogation revealed the eri battery status, three charging cycles were documented to the devices memory.The device was subjected to an electrical analysis.The amount of charge taken from the battery was verified.The battery condition was found to be normal and as expected.Afterwards, the current consumption of the icd was measured and found to be elevated, confirming the clinical observation.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.In a next step the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.Further electrical investigations revealed that an integrated circuit of the electronic module was damaged, causing an elevated current consumption, draining the battery.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, a damaged integrated circuit on the electronic module was identified, that led to an elevated current consumption and thus, to the clinical observation.The manufacturing records document a normal device production.It is therefore assumed that the damage occurred after the device shipment, however the date of occurrence was not determinable.All therapy functions of the icd were available while the device was implanted and in service.

• Brand Name: INTICA NEO 7 HF-T QP DF-1 IS4 PROMRI
• Common Device Name: 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: 15815303
• Report Number: 1028232-2022-05882
• Device Sequence Number: 20183997
• Product Code: NIK
• UDI-Device Identifier: 04035479156824
• UDI-Public: (01)04035479156824(17)230430
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2022

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: 04/30/2023
• Device Model Number: 429552
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 11/22/2022; 03/17/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 11/29/2022; 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male