MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG VOLTA 1CR 65 US; ICD LEAD

Model Number	384075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Unspecified Infection (1930)
Date of Event	11/14/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In summary, the infection was not device related.
Event or Problem Description
Livanova/microport provided the following information: on (b)(6) 2017, patient presented 2 weeks status-post right toe/foot resection complaining of right foot pain, erythema and swelling.Foot culture (b)(6) for (b)(6).Treatment plan per infectious disease.On (b)(6) 2017, patient presented to emergency department with worsening shortness of breath, lower extremity edema and ascites.Blood cultures (b)(6) for (b)(6) on (b)(6) 2017, and (b)(6) 2017.Treated with intravenous daptomycin.Right foot now consistent with osteomyelitis.On (b)(6) 2017, device site was erythemous.Device and three leads were extracted on (b)(6) 2017.Tissue showed evidence of infection (b)(6) for (b)(6).On (b)(6) 2018, following six weeks of outpatient daptomycin, blood culture from (b)(6) 2018 was (b)(6) for (b)(6).Switched to intravenous vancomycin.Patient never fully recovered from systemic (b)(6) infection and eventually passed away.

• Brand Name: VOLTA 1CR 65 US
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 10311518
• Report Number: 1028232-2020-03008
• Device Sequence Number: 3398715
• Product Code: NVY
• UDI-Device Identifier: 04035479143374
• UDI-Public: 04035479143374
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 384075
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death