MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ACCENT DR RF PACEMAKER; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2210

Device Problem Failure to Capture (1081)

Patient Problem Seizures (2063)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2938836-2019-04940.It was reported that the patient had two seizures due to low heart rate from suspected loss of capture on the rv lead.Intermittent capture and increased impedance were observed over the last few months.The device was reprogrammed.The rv lead was capped on (b)(6) 2019 and replaced.The device was explanted and replaced.The patient was stable before, during, and after procedure.

Manufacturer Narrative

The reported field event of impedance and capture anomaly was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8761145
• MDR Text Key: 150104712
• Report Number: 2938836-2019-04939
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734503617
• UDI-Public: 05414734503617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: PM2210
• Device Lot Number: 3625671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2012
• 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): Other; Required Intervention