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

Model Number	429571
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pneumothorax (2012); Vascular Dissection (3160)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8547483
• Report Number: 1028232-2019-01605
• Device Sequence Number: 1744104
• Product Code: NIK
• UDI-Device Identifier: 04035479156978
• UDI-Public: 04035479156978
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 429571
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization