MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INLEXA 3 DR-T DF-1 PROMRI; ICD

Model Number 404701

Device Problems Failure to Deliver Shock/Stimulation (1133); Low impedance (2285)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/07/2021

Event Type  Death  

Event Description

The patient died.It was reported that the patient suffered ventricular fibrillation and collapsed.The resuscitation was unsuccessful.Reportedly the icd did not deliver any shock therapy and the shock impedance was < 20 ohms.Should additional information be received, this file will be updated.

Manufacturer Narrative

The safio leads were not available for investigation.The analysis is thus based on the inspection of the returned icd as well as the plexa lead.Icd analysis results: the manufacturing processes for the icd was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance tests proved the device functions to be as specified.There was no indication of a material or manufacturing problem of these devices.The icd was visually inspected.Arcing marks were observed on the edge of the housing near the df-1 port.The icd was interrogated.The battery status was bos.In total 65 episodes were recorded of which episodes no.15 to 65 were recorded after the patients death.Episode 14 which started on (b)(6), 2021 at 9:17 pm.Shows a regular vf-detection as well as several re-detections according to the programmed parameters.In the course of that episode one atp (anti-tachycardia pacing) was delivered without success followed by 8 shocks which were aborted because of too low shock impedance.This is consistent with the observed arcing marks and points towards a too low impedance (short circuit) between the shock lead and the icd case.By design the internal statistics comprises historical data for 240 days due to memory limitations.Therefore, no impedance trend data are available for the period while the icd was still implanted.The impedance measurement functionality was tested by connecting a defined 50 ohm resistor.The measurement of the shock impedance proved to be accurate and as expected, however, the too low impedance between shock lead and icd case was only detectable under high-voltage conditions like it is the case during shock delivery.In contrast, low-voltage impedance measurements which are automatically conducted by the icd were normal and did not indicate any low impedance.The icd was subjected to further 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 normal sensing and shock delivery as expected.In particular, the specified shock energy level was reached.In summary, the memory content as well as the functionality of the icd proved the device to be fully functional.There was no indication of an icd malfunction.Arcing marks on the icd houses indicate an external short circuit to be the root cause for the aborted shocks in episode 14.Lead analysis results: in the course of the visual inspection the is-1 connector was found capped with a bk-is (lead cap).The cap was removed from the connector, the is-1 connector did not show any contact marks.The df-1 connector showed contact marks indicating proper connection to the device header while implanted.There were no ligature marks noted on the lead body.The suture sleeve was not returned for analysis.The insulation of the df-1 connector was found breached 2.5 cm distal to the pin.In this region coagulated and dried blood residuals were noted.The lead was reconnected to the icd header showing that the region of the insulation damage was consistent with the arcing marks on the generator housing.Distal to the insulation breach, the insulation body showed a slight abrasion mark.The partially breached insulation 2.5 cm distal to the df-1 connector pin was cut completely in order to examine the kink protection coil underneath.The kink protection coil showed residuals of coagulated and dried blood in this region and material melt of one wire winding.In the region of the insulation breach the adhesive surfaces of both silicone sleeves were inspected.The adhesive residuals indicated a proper bonding and no material or manufacturing problem.In the course of the mechanical analysis a stylet was completely inserted within the leads lumen and the fixation helix could be properly extended and retracted.No peculiarities were noted.Resistance testing was completed to assess the leads electrical performance.The measurements throughout these tests were within normal limits.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly.Especially the steps referring to the silicone bonding were carried out properly.The final acceptance tests proved the device functions to be as specified, including a thorough examination of the insulation.For this purpose a high voltage test was performed while the df-1 connector was completely immersed in saline solution.The voltage applied multiple times during the test as well as the pulse duration were significantly higher compared to a clinical situation proving the insulation to be as specified.Conclusion of the icd and lead analysis: based on the analysis results of this investigation it is assumed that the lead was subject to severe mechanical stress in the pocket area.The damage on the df-1 connector indicates that the lead was kinked in this region, presumably due to a tight winding in the pocket which led to a breach of the insulation and subsequently to a short circuit path between the generator housing and the kink protection coil of the lead.Based on the instructions for use it is recommended placing the excess lead length around the active device in loose loops to prevent a kinking of the lead.In conclusion, the analysis of the devices did not reveal any sign of a material or manufacturing problem.Particularly the final acceptance test including a high voltage test of the lead proved the device functions to be as specified.The observed arcing marks on the icd housing are consistent with the insulation breach on the shock lead which is most likely the root cause of the observed low impedance.

• Brand Name: INLEXA 3 DR-T DF-1 PROMRI
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17273158
• MDR Text Key: 318512179
• Report Number: 1028232-2023-03289
• Device Sequence Number: 1
• Product Code: MRM
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 404701
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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