MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INLEXA 7 DR-T DF-1; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number 404640

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Charged against vf, but no shock emission due to abnormal resistance value (below 20 ohms).The shocking lead is suspected to be defective.Device remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned data.The manufacturing process 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 test proved the device functions to be as specified.The returned data was inspected.During inspection of the available iegms, the clinical observation could be confirmed.The iegms documented five regular detected vf episodes with several charging cycles of the high voltage capacitors.The charging cycles were aborted, as expected, due to the detection of an external short circuit, which might have otherwise damaged the icd.There was no indication of an icd malfunction.In conclusion, the icd was not returned for analysis.The returned data revealed no indication of an icd malfunction.Based on the analysis, it is reasonable to assume that the clinical observation resulted from a lead damage.

• Brand Name: INLEXA 7 DR-T DF-1
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15616356
• MDR Text Key: 301995849
• Report Number: 1028232-2022-05322
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 404640
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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