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

Model Number 429522

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Inflammation (1932)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Event Description

The patient was transferred from another hospital due to suspected pacemaker pocket infection, reddening was seen.The patient suffered from fatigue, weakness, and feeling cold for a couple of days.After treatment the inflammation parameters and reddening decreased.Patient presented in good general condition, cardiopulmonary compensated and hemodynamic stable.The patient was hospitalized.Lab test was done, inflammation and kidney parameters were checked and a bacteriological smear was taken.Echocardiography was done without indication of endocarditis.Antibiotic therapy was started with vancomycin and co-amoxicillin and continued for 14 days.Crt explantation and leadless pacemaker implantation were done.In long term a new re-evaluation for crt-d re-implantation will be discussed.

• Brand Name: ACTICOR 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11565761
• MDR Text Key: 242175499
• Report Number: 1028232-2021-01404
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156671
• UDI-Public: 04035479156671
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 429522
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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 Outcome(s): Hospitalization