MAUDE Adverse Event Report: LIVANOVA, FORMERLY SORIN STOCKERT SORIN 3T HCD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Inflammation (1932)

Event Type  Injury  

Event Description

Pt hospitalized in (b)(6) 2016 with osteomyelitis sternum.Initial testing positive for mycobacterium chimaera.Further testing underway.Results not yet back.

• Brand Name: STOCKERT SORIN 3T HCD
• Type of Device: STOCKERT SORIN 3T HCD
• Manufacturer (Section D): LIVANOVA, FORMERLY SORIN
• MDR Report Key: 6181547
• MDR Text Key: 62597597
• Report Number: MW5066735
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 118