MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 3 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 429571

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pneumothorax (2012); Vascular Dissection (3160)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.The device is currently not available for analysis.Therefore, no conclusion can be drawn at this time.However, biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.Should additional relevant information become available, this investigation will be updated.

Event Description

Ous mdr - the patient suffered from a hemopneumothorax on the left side after crt-d implantation and a diffuse bleeding of the chest wall in the area of the clavicle was recognized.During the implantation two dissections of the coronary sinus were described due to dislodgement of the whole system two times.The patient was hospitalized.Ct scan was performed for diagnostic reasons.A thoracotomy was done and the hematoma removed.Antibiotics were given perioperative.Should additional information be received, this file will be updated.

• Brand Name: RIVACOR 3 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: 8547483
• MDR Text Key: 143019092
• Report Number: 1028232-2019-01605
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156978
• UDI-Public: 04035479156978
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 429571
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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
• Patient Outcome(s): Hospitalization