MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ACCENT DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2212

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); No Pacing (3268)

Patient Problems Syncope (1610); Fainting (1847)

Event Date 12/14/2018

Event Type  Injury  

Event Description

The patient went into the emergency room due some episodes of syncope.Interrogation of the device revealed several episodes of oversensing due to noise and suspected electromagnetic interference (emi) resulting in loss of pacing.Device reprogramming was first attempted but failed.The device was finally explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported noise anomaly was confirmed.Morphology and frequency of noise observed in provided session records is consistent with an oversensing issue related to hourly impedance measurements.The reported event of no output was not confirmed.The device output measurements using an oscilloscope found the device output was within specified tolerances.Output monitoring during environmental stress testing found no loss of output.Evaluation of the device header found no defect that could contribute to the complaint of no output.

• Brand Name: ACCENT DR RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8209071
• MDR Text Key: 131809135
• Report Number: 2017865-2019-00013
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: 02/28/2014
• Device Model Number: PM2212
• Device Lot Number: 3794576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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): Hospitalization; Required Intervention