MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40

Device Problems Over-Sensing (1438); Device Operates Differently Than Expected (2913)

Patient Problems Complete Heart Block (2627); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  Injury  

Event Description

It was reported that a patient presented with the device and right ventricular lead oversensing via merlin.Net transmission.Episodes of ams due to oversensing were also noted.Review of the episodes confirmed unspecified oversensing, possibly caused by environmental noise, far-field signals or lead noise.The patient is currently stable and scheduled for revision.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information: noise was reproducible in clinic with isometrics.New information received indicates that the patient presented for a lead revision.Psa testing was clear and noise was not reproducible.Rv lead was capped and replaced.There were a couple episode of noise on competitor's ra lead.The patient became pacemaker dependent possibly due to the rv lead placement on the septum that knocked out the right bundle branch.The patient developed complete heart block by the end of the case.The patient was stable post procedure.

Manufacturer Narrative

No conclusion code available.The reported field event of oversensing was confirmed in the device image.Bench testing found the device to be normal.The cause of the reported event remains undetermined.

Event Description

The device was explanted on (b)(6)2018.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7301333
• MDR Text Key: 101159371
• Report Number: 2938836-2018-01732
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: CD3231-40
• Device Catalogue Number: CD3231-40
• Device Lot Number: 3137563
• Other Device ID Number: 0514734504362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 02/13/2018; 09/13/2018; 10/01/2018
• Supplement Dates FDA Received: 03/12/2018; 09/18/2018; 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 83