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

Model Number PM1210

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Dizziness (2194)

Event Date 02/10/2020

Event Type  malfunction  

Event Description

Related manufacturer reference number:2017865-2020-02690.It was reported that the patient presented in clinic with light headedness.It was noted that the right ventricular lead had noise.The noise could be reproduced.On (b)(6) 2020, the patient presented for a lead revision.The lead was capped and replaced.During the procedure, it was noted that the pacemaker had blood in the header port.The device was explanted and replaced.The patient was stable before, during, and after the procedure.

Manufacturer Narrative

Analysis testing found blood at the proximal end of the connector but was stopped at the connector entry zones.There was no blood flow past this point.Blood in the distal end of the connector tip most likely flowed into the distal tip of the connector through the opening in the lead pin.The blood was isolated to this area.No header damage was found.Blood in these areas are normal and do not pose a risk.All connector dimensions were normal.The device was found electrically normal.The battery voltage is above eri.

• Brand Name: ACCENT SR RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9763594
• MDR Text Key: 181528497
• Report Number: 2017865-2020-02691
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: 05414734502757
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: PM1210
• Device Catalogue Number: PM1210
• Device Lot Number: 3327056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL ST
• Patient Age: 67 YR
• Patient Weight: 145