MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI DF-1 S DX 65/15; ICD LEAD

Model Number 414005

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problems Unspecified Infection (1930); Shock from Patient Lead(s) (3162)

Event Date 04/05/2024

Event Type  Injury  

Event Description

Rv lead had noise, inappropriate shock, and fracture.System was explanted due to infection due to breast surgery.Possible that surgery caused lead damage.Should additional information become available, this file will be updated.

• Brand Name: PLEXA PROMRI DF-1 S DX 65/15
• Type of Device: ICD LEAD
• 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: 19168557
• MDR Text Key: 340874933
• Report Number: 1028232-2024-02205
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 04035479151027
• UDI-Public: (01)04035479151027(17)200430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980023
• 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
• Report Date: 04/23/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 414005
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 04/24/2018
• 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
• Patient Age: 68 YR
• Patient Sex: Female