MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI DF-1 SD 65/18; ICD LEAD

Model Number	414001
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Noise can be seen via hmsc recordings beginning on (b)(6) 2023.Patient is dependent.Lead remains implanted.No adverse events reported.
Additional 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.
Additional Manufacturer Narrative
(b)(6) 2023 lead explanted.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.

• Brand Name: PLEXA PROMRI DF-1 SD 65/18
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16241368
• Report Number: 1028232-2023-00383
• Device Sequence Number: 12417855
• Product Code: NVY
• UDI-Device Identifier: 04035479151003
• UDI-Public: (01)04035479151003(17)190630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 414001
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 01/26/2023; 03/30/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 01/26/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown