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

Model Number	414001
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Shock impedance > 150 ohms on home monitoring.Patient had previous lead extracted, and this lead implanted on (b)(6) 2020.2 days after implant lead began reporting shock impedance <150.Patient brought to office on (b)(6) 2020, and in office 5/5 measurements showed impedance in normal range.No noise could be elicited and postural testing was also completed.Lead remains implanted.
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.

• 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
• MDR Report Key: 10542291
• Report Number: 1028232-2020-03951
• Device Sequence Number: 3161851
• Product Code: NVY
• UDI-Device Identifier: 04035479151003
• UDI-Public: 04035479151003
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 02/28/2022
• Device Model Number: 414001
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR