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

Model Number PM2162

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2020-23013.During an in clinic follow-up, high pacing impedance and a loss of capture were observed on the right atrial (ra) lead.Abbott technical support was contacted and suspected the electrical anomalies may be due to inadequate connection between the ra lead and the header of the pacemaker.No intervention was performed at this time.The patient was stable and will continue to be monitored.

Manufacturer Narrative

This mdr report product is for an ous event identified as same/similar during a retrospective review as a result of abbott¿s investigation.

Manufacturer Narrative

Correction: g3 - date received by manufacturer should have been aug 18, 2022, not dec 1, 2020, as reported in follow-up report number 1.

• Brand Name: ENDURITY PACEMAKER, DR, MRI RESTRICTED
• 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: 15237382
• MDR Text Key: 302930855
• Report Number: 2017865-2022-19525
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PM2162
• Device Lot Number: P000107910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 12/01/2020; 08/24/2022
• Supplement Dates FDA Received: 08/18/2022; 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• 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