MAUDE Adverse Event Report: ST. JUDE MEDICAL, IMPLANTABLE ELECTRONIC SYSTEMS DIVISION UNIFY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number UNIFY 3231

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

Patient Problem Complete Heart Block (2627)

Event Date 11/18/2016

Event Type  malfunction  

Event Description

The patient was part of sjm unify 3231 advisory alert.The patient has underlying rhythm of complete heart block (chb).The decision was made to prophylactically change out the device, as recommendation is that if the device triggers alert, generator change should be immediate (within 24 hours).

• Brand Name: UNIFY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, IMPLANTABLE ELECTRONIC SYSTEMS DIVISION; 645 almanor ave.; sunnyvale CA 94085
• MDR Report Key: 6228808
• MDR Text Key: 64056399
• Report Number: 6228808
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/28/2016,12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNIFY 3231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2016
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 11/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 92 YR