MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ABBOTT PACEMAKER; implantable pacemaker Pulse-generator

Model Number ABBOTT PM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested, but not received.

Event Description

It was reported, that the pacemaker was explanted, due to an unspecified infection.The patient condition was stable.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.Correction: the correct statement in b5 should have been "it was reported that the patient presented for a follow-up in the clinic with an unspecified infection and pocket erosion at the implant site.The device pocket was noted to swelling.The physician explanted the whole system- pacemaker, right ventricular lead and right atrial lead.The patient was in stable condition." rather than "it was reported that the pacemaker was explanted due to an unspecified infection.The patient condition was stable." the correct serial number should have been "(b)(6)".The correct model should have been "pm2272", rather than "abbott pm.".

Event Description

It was reported that the patient presented for a follow-up in the clinic with an unspecified infection and pocket erosion at the implant site.The device pocket was noted to swelling.The physician explanted the whole system- pacemaker, right ventricular lead and right atrial lead.The patient was in stable condition.

• Brand Name: ABBOTT 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18490670
• MDR Text Key: 332601260
• Report Number: 2017865-2024-00945
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140033
• 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
• Report Date: 01/17/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ABBOTT PM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention