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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 DR-T DF-1 PROMRI; ICD
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BIOTRONIK SE & CO. KG ILIVIA 7 DR-T DF-1 PROMRI; ICD Back to Search Results
Model Number 404622
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2019
Event Type  malfunction  
Event Description
Ous mdr - the shock impedance showed over 150 ohms and an icd lead malfunction was suspected.During the revision, after disconnecting the lead from this icd the lead shock impedance showed normal value.It was found that the problem was connection.This icd was removed from the patient and the lead remains implanted and active.
 
Event Description
Ous mdr - the shock impedance showed over 150 ohms and an icd lead malfunction was suspected.During the revision, after disconnecting the lead from this icd the lead shock impedance showed normal value.It was found that the problem was connection.This icd was removed from the patient and the lead remains implanted and active.
 
Manufacturer Narrative
The lead was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of the lead and the icd as well as the analysis of the icd itself.The manufacturing process for these devices was re-investigated.There was no sign of any inconsistency during the manufacturing process which may be related to the observed symptoms.Particularly the final acceptance test of the icd proved the device functions to be as specified.The icd was received and analyzed.The memory content of the icd was inspected, confirming the clinical observation.The trend data showed values of the shock impedance greater than 150 ohm since (b)(6) 2019.The header of the icd was visually inspected.The visual inspection revealed that the set screw of the rv df-1 channel was screwed in upon receipt.The silicone sealing belonging to this set screw was damaged.Furthermore the hexagon socket was rounded, indicating the presence of strong external forces during implantation and connection of the corresponding icd lead.In a next step, a sensing test was performed and the device sensed the attached heart signals free of noise.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.The impedance measurement functions did not show any anomaly.In conclusion, the set screw of the rv df-1 channel was found damaged, presumably due to strong mechanical forces applied in the course of the surgery.The root cause of the clinical observation was not determinable.The icd functioned as expected during analysis.A poor connection between the lead and the icd cannot be excluded, as mentioned in the complaint description.There was no indication of a material or manufacturing problem.
 
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Brand Name
ILIVIA 7 DR-T DF-1 PROMRI
Type of Device
ICD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key8579829
MDR Text Key144125300
Report Number1028232-2019-01797
Device Sequence Number1
Product Code MRM
UDI-Device Identifier04035479142094
UDI-Public04035479142094
Combination Product (y/n)N
PMA/PMN Number
P050023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2020
Device Model Number404622
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Date Manufacturer Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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