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

Model Number 429522

Device Problem Premature End-of-Life Indicator (1480)

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

Event Date 04/18/2024

Event Type  malfunction  

Event Description

Device was found to be at eos during (b)(6) 2024 interrogation.Device was programmed with normal outputs and no shocks delivered, only continuous pacing.Patient was struck by a moving vehicle in (b)(6) 2023 and had an mri scan where mri autodetect was reportedly programmed.It was unclear whether the device may have charged for shock therapy during the scan.Device is currently implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.

• 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: 19140037
• MDR Text Key: 340818873
• Report Number: 1028232-2024-02160
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479156671
• UDI-Public: (01)04035479156671(17)230131
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• 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: 04/18/2024
• Date Device Manufactured: 01/21/2021
• 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: 56 YR
• Patient Sex: Male