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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA NEO 7 DR-T DF-1 PROMRI; ICD
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BIOTRONIK SE & CO. KG INTICA NEO 7 DR-T DF-1 PROMRI; ICD Back to Search Results
Model Number 429558
Device Problems High impedance (1291); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  malfunction  
Event Description
After an implantation period of approximately 20 days it was reported that the icd was explanted due to high shock impedance.A connection issue was observed between lead and icd during the explantation procedure.
 
Manufacturer Narrative
The lead was not returned for analysis.Therefore, this report is solely based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacturing of the lead and the icd.The manufacturing processes for these devices were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing.Particularly the final acceptance tests proved the devices functions to be as specified.The icd was inspected in detail.Header analysis showed that the set screw of the df-1 rv channel was fully screwed in, impeding the lead to be inserted into the header bore.However, further inspection of the set screw showed screw marks, indicating that the lead had been previously properly connected.Analysis showed no anomalies.In a next step, the icd was interrogated, revealing the bos battery status.No charging cycles were recorded to the devices memory.The inspection of the memory content confirmed the clinical observation.Therefore, the impedance measurement functions of the device were tested and proved to be normal.The clinical observation could not be reproduced.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, and the shock impedance was as expected.In conclusion, the memory content as well as the therapeutic functionality of the icd were thoroughly analyzed.The analysis of the memory content confirmed the clinical observation.However, an extensive analysis of the icd proved the icd to be fully functional.All measured impedance values were normal.There was no indication of device malfunction.
 
Event Description
After an implantation period of approximately 20 days it was reported that the icd was explanted due to high shock impedance.A connection issue was observed between lead and icd during the explantation procedure.The event date was updated.
 
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Brand Name
INTICA NEO 7 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 Key15068181
MDR Text Key296295880
Report Number1028232-2022-03666
Device Sequence Number1
Product Code MRM
UDI-Device Identifier04035479156848
UDI-Public04035479156848
Combination Product (y/n)N
PMA/PMN Number
P000009
Number of Events Reported1
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 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model Number429558
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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