MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA S 60; ICD LEAD

Model Number	395722
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation (2443)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
System was explanted because the patient seemed to be allergic to the epoxy and resins.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
We received the lead and your event description.The information you provided has been entered into our quality system as a complaint.Allergy to the epoxy and resins was observed following the implantation of this biotronik device.Therefore the lead as received was visually and electrically inspected.A bent distal end and a df-4 connector pin were found, which most likely occurred due to mechanical forces applied during the surgery.The quality documents associated with the manufacture of this particular lead were re-investigated.There was no sign of any inconsistency during production and final acceptance test.Please note that no epoxy resin materials are used to manufacture plexa leads.In conclusion there was no indication of a material or manufacturing problem.

• Brand Name: PLEXA S 60
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10393590
• Report Number: 1028232-2020-03352
• Device Sequence Number: 19301492
• Product Code: NVY
• UDI-Device Identifier: 04035479133139
• UDI-Public: 04035479133139
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 395722
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR