MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 5 DR-T DF-1 PROMRI; ICD

Model Number	429568
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rv lead (linox smart sd) was capped due to low shock impedance measurements approx.109 months after the implantation.During the revision surgery the associated icd was prophylactically exchanged after 9 months of implantation period.This icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.
Additional Manufacturer Narrative
The icd was received for analysis and inspected.Upon receipt, the icd was interrogated, revealing the bos battery status and two charging cycles were recorded to the devices memory.The battery condition was found to be as expected and the current consumption was normal.The memory content of the icd was inspected, showing a low shock impedance with a greater relative rv lead impedance change since november 2020.Therefore, the impedance measurement functions as well as the sensing functionality of the device were tested and proved to be fully functional.The device sensed the attached heart signals free of noise and the measured impedances were normal and as expected.There was no indication of a device malfunction.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 and the shock impedance was as expected.The lead was not returned for analysis.However, the manufacturing process for lead was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, during analysis the icd was fully functional.There was no indication of device malfunction.

• Brand Name: INTICA NEO 5 DR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11819384
• Report Number: 1028232-2021-02612
• Device Sequence Number: 19769918
• Product Code: MRM
• UDI-Device Identifier: 04035479156947
• UDI-Public: 04035479156947
• Combination Product (Y/N): N
• PMA/510(K) Number: P000009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 11/30/2021
• Device Model Number: 429568
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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