MAUDE Adverse Event Report: MEDTRONIC BIOCAL 370 SN

Model Number BIO/CAL 370 SN

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 07/15/2015

Event Type  Injury  

Event Description

Pt developed mycobacterium abscessus infection approx 4 months post cabg x 3 and aortic valve replacement.

• Brand Name: BIOCAL 370 SN
• Type of Device: BIOCAL 370 SN
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55422
• MDR Report Key: 5117839
• MDR Text Key: 27310660
• Report Number: MW5056737
• Device Sequence Number: 1
• Product Code: DWJ

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: PHYSICIAN
• Type of Report: Initial
• Report Date: 09/24/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/24/2015
• Is This An Adverse Event Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/24/2018
• Device MODEL Number: BIO/CAL 370 SN
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 09/24/2015 Patient Sequence Number: 1