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

Model Number PM2210

Device Problem Failure to Capture (1081)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient's pacemaker was experiencing loss of capture.The pacemaker was explanted and replaced with alternate pacemaker.

Manufacturer Narrative

The reported event of failure to capture was not confirmed.The device was at elective replacement indicator (eri) level upon receipt.Electrical and mechanical analysis performed indicated normal functionality, and capture test performed under nominal conditions found no anomaly.Additionally, visual inspection of the header and connectors detected no contamination or foreign material that could contribute to the reported event.Longevity assessment was performed based on average drain current and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17188697
• MDR Text Key: 317719888
• Report Number: 2017865-2023-24020
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: 05414734503617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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: 09/30/2014
• Device Model Number: PM2210
• Device Catalogue Number: PM2210
• Device Lot Number: 4009603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2013
• 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
• Treatment: TENDRIL LEAD; TENDRIL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male