MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 HF-T DF4 IS-1 PROMRI; NO MATCH

Model Number 429533

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 08/23/2022

Event Type  Death  

Event Description

The patient experienced cardiac arrest on (b)(6) 2022 and a magnet was applied to the device before resuscitation.The physician called for a device check after resuscitation.During the device check, tachy detection was found to be off while no magnet was applied.It is suspected that tachy detection and therapy was not restored after removal of the magnet.Tachy detection was enabled at the follow up.The patient has since expired.

Manufacturer Narrative

The icd and fragments of the leads were returned for analysis.Upon receipt, the leads were still connected to the icd header.Incoming visual inspection showed no anomalies.In a next step, the leads were disconnected from the icd and the devices were analyzed.Incoming icd interrogation revealed the battery status bos.No charging cycles were documented.The memory content of the icd was inspected, showing a normal device function while implanted and in service.The analysis revealed that a magnet application was detected by the device on (b)(6) 2022.As a result, a message box was shown on the programmer screen at first interrogation on (b)(6) 2022 at 10:00h, informing about the magnet application and asking whether the anti-tachycardia detection should be disabled.This message box was closed by pressing the yes button at 10:32h, which led to the clinical observation.There was no indication of a device malfunction.The icd was subjected to an electrical analysis.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 correct sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the icd proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.There was no indication of an icd malfunction.The received leads were found cut next to the connector pin.The proximal fragment of the leads were received for analysis.It is reasonable to assume that the leads were cut during the explantation procedure.The insulation of the leads was apart from the present cut, free of breaches.Further inspection of the leads did not show any deviations that might have contributed to the clinical observations.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: RIVACOR 7 HF-T DF4 IS-1 PROMRI
• Type of Device: NO MATCH
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15422490
• MDR Text Key: 299924716
• Report Number: 1028232-2022-04745
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 429533
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death