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

Model Number 429532

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Implant Pain (4561)

Event Date 12/29/2020

Event Type  Injury  

Event Description

There was a pocket revision being done due to the device migrating.It was originally implanted subpectoral and was causing the patient pain because it migrated.During the revision the physicians tools scratched up the device and so to be cautious they asked for a new device.Should additional information be received, this file will be updated.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.

Manufacturer Narrative

The device was received and visually inspected.The device was normal and as expected.There was no indication of a deviation from the mechanical specification.A review of biotroniks post market surveillance database did not reveal any trend for this type of event.In conclusion, the device was mechanically as expected.The root cause for the observed device migration could not be determined.

• Brand Name: RIVACOR 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: 11116506
• MDR Text Key: 225053608
• Report Number: 1028232-2021-00027
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156770
• UDI-Public: (01)04035479156770(17)220131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 429532
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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 Age: 77 YR
• Patient Sex: Female