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

Model Number PM2210

Device Problems Incorrect Measurement (1383); Pacing Intermittently (1443)

Patient Problem Arrhythmia (1721)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital with bradycardia.Upon interrogation the pacemaker was pacing intermittently.Additionally, the device stated that the battery reached elective replacement indicator on (b)(6) 2021 but had reached end-of-life voltages on (b)(6) 2021, indicating a device diagnostic issue.The pacemaker was explanted and replaced.The patient was in stable condition post-procedure.

Manufacturer Narrative

The reported event of pacing intermittently and incorrect elective replacement indicator (eri) date were confirmed.The pacemaker was returned for analysis past end of life (eol).Interrogation of the device revealed the incorrect eri alert was a result of the true eri alert reached on (b)(6) 2020 being overwritten when the pacemaker went past eol.Analysis shows the pacemaker reached eol in (b)(6) 2020 and the pacemaker was pacing intermittently due to the battery voltage being too low to support normal function.Longevity analysis showed normal battery depletion occurred indicating this was expected device behavior.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12871088
• MDR Text Key: 281277499
• Report Number: 2017865-2021-37538
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: 08/31/2012
• Device Model Number: PM2210
• Device Catalogue Number: PM2210
• Device Lot Number: 3319085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2011
• 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 SDX; TENDRIL SDX
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White