MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 HF-T DF4 IS-1 PROMRI; NO MATCH

Model Number 429533

Device Problem Battery Problem (2885)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

An unexpected decrease of the remaining battery charge was observed.Device currently 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 available data.The manufacturing process for this device 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 icd functions to be as specified.The available data have been analyzed.Analysis revealed that the clinical observation resulted from a temporarily elevated current consumption in the period between (b)(6) and (b)(6), 2021.The root cause of the temporarily elevated current consumption was not determinable.However, since (b)(6) 2021, the current consumption is normal, and the icd functions as expected.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.

• Brand Name: RIVACOR 7 HF-T DF4 IS-1 PROMRI
• Type of Device: NO MATCH
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17780712
• MDR Text Key: 323831194
• Report Number: 1028232-2023-04657
• 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
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 429533
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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