MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INVENTRA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 393011

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 11/27/2022

Event Type  malfunction  

Event Description

It was reported that the device showed the eos status approximately 89 months after the implantation due to multiple inappropriate shocks.Device remains implanted at this time.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd and the lead under complaint were not returned for analysis.The analysis is therefore only based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned data.The manufacturing processes for the icd and the lead were re-investigated.All production steps were performed accordingly.There was no sign of any inconsistency during manufacturing.The final acceptance tests proved the devices functions to be as specified.The returned data have been inspected, confirming the clinical observation.Based on the data there was no indication of an icd malfunction and the battery status is anticipated.In conclusion, the clinical observation was confirmed.The icd functioned as expected based on the available data.There was no indication of a material or manufacturing problem for the icd or the lead.

• Brand Name: INVENTRA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15937301
• MDR Text Key: 305071265
• Report Number: 1028232-2022-06304
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 393011
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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