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
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR
• Patient Weight: 97