MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); PERMANENT PACEMAKER ELECTRODE

Model Number 1458QL/86

Device Problem High Capture Threshold (3266)

Patient Problem Congestive Heart Failure (1783)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the left ventricular lead was thought to have displaced over a scar.The patient had returned to the hospital with congestive heart failure symptoms.There was no x-ray reviewed to confirm lead dislodgment.The lead was not capturing in most vectors and the one vector that was able to capture noted high threshold.The lead was explanted and replaced.The patient was fine during and after the procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6391679
• MDR Text Key: 69493632
• Report Number: 2938836-2017-17896
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

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: 05/31/2019
• Device Model Number: 1458QL/86
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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 Age: 78 YR