MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 404630

Device Problems Low impedance (2285); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020, rv lead impedance dropped below 200 ohms.From the iegm, it seemed like noise was observed.The patient visited the hospital for a device check, and the lead impedance was normal with normal thresholds.Pacing was applied with a high output, but there was no noise on the iegm (even with physical manipulation).Therapy was turned off in order to avoid inappropriate therapy.On (b)(6) 2020, the system was replaced and the physician requested analysis of the device.

Manufacturer Narrative

The lead under complaint was not returned for investigation.Therefore this report only refers to the results of the icd analysis.Upon receipt, the icd was interrogated, revealing the mos1 battery status, 16 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During analysis of the available iegms noise was observed in all channels.The device data further showed one documented ventricular pacing impedance of 200 ohm on (b)(6) 2020.Therefore the impedance measurement functions as well as the sensing functionality of the device were thoroughly 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.In a next step, 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 conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed.Additionally, one documented ventricular pacing impedance of 200 ohm was noticed on (b)(6) 2020.However, a thorough analysis of the icd, especially of the sensing and impedance measurement functions, proved the device to be fully functional.

• Brand Name: INTICA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10373957
• MDR Text Key: 201887040
• Report Number: 1028232-2020-03267
• Device Sequence Number: 1
• Product Code: NIK
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 404630
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization