MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 5 DR-T PROMRI DF4; ICD

Model Number 390117

Device Problems Failure to Capture (1081); Failure to Sense (1559); Ambient Noise Problem (2877)

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

Event Date 02/02/2017

Event Type  malfunction  

Event Description

Ous mdr - the system was implanted on (b)(6) 2017.On (b)(6) 2017 during a follow up, it was noted that there were many aborted shocks due to noise in the ventricular channel.When the patient moves his arm there is noise on the iegm.A fluoroscopy was performed and the lead was not dislodged.The physician decided to do a lead revision.There was no sensing and no capture even at 7.5v for the ventricle.The physician decided to remove the whole system.Should additional information be received, this report will be updated.

Manufacturer Narrative

The icd and the leads under complaint were returned and subjected to an extensive analysis.Upon receipt, the icd was interrogated, revealing the battery status mos1.The icd was implanted for 15 days and 284 charging cycles were recorded to the icds memory.The header of the icd was visually inspected, revealing no anomalies.The set screws could be easily screwed in and out; there was no foreign material inside the header bores.The set screws showed screw marks on the bottom side indicating that they were tightened during the implantation.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel, as mentioned in the complaint description.Therefore a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.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 correct sensing and shock delivery.In particular, the specified energy level was reached.During the visual inspection of the safio, cuts in the insulation were found 20 cm and 24 cm distal to the is-1 connector pin.It is reasonable to assume, that the cuts resulted from the explanted procedure.Blood penetrated the lead in these areas.Subsequently the protego promri was analyzed, revealing two set screw marks on the df4 connector pin, displaced by 1 mm.This finding might have resulted from an incorrectly tightened set screw.Further analysis of the leads did not reveal any irregularity that might have contributed to the reported clinical event.The manufacturing process for these devices was re investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.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 in the right ventricular channel.However, a thorough analysis of the icd and the leads did not reveal any indication of a malfunction.The icd proved to be fully functional.Based on the information available for analysis, the root cause of the clinical observation was not determinable.However, considering the marks observed on the protego df4 connector pin and the morphology of the noise signals, it cannot be excluded that the clinical event resulted from an incorrectly tightened set screw.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: IFORIA 5 DR-T PROMRI DF4
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6394924
• MDR Text Key: 69741924
• Report Number: 1028232-2017-00584
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 390117
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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): Hospitalization