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

Model Number PM2272

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Use of Device Problem (1670); Defective Device (2588); Connection Problem (2900)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that during an elective generator replacement procedure, the pacemaker exhibited high pacing impedance, header anomaly and inadequate lead insertion alleged on the device header.The device was not used and another device was used to complete the procedure.The patient was discharged with no further adverse consequences reported.

Event Description

New information received notes that the device was unable to be implanted, with malfunction alleged on the device.Additionally, a set-screw anomaly was alleged on the device.No further patient consequences were reported.

Manufacturer Narrative

The reported complaint of the atrial lead could not be tightened in the connector was confirmed.Analysis found epoxy on atrial contact spring.The epoxy was found gluing multiple loops of the spring together.The epoxy prevented the spring loops from expanding and from the loops sliding apart to allow the lead to insert through it.Since the spring could not expand and rotate due to the epoxy the spring was pushed out of its slot and was pushed down in the connector port by the lead.The spring is now blocking the lead from fully inserting into the connector port.Without full lead insertion and the spring out of the slot the lead impedance reading will be >3000 ohms.Also the setscrew cannot tighten down on the lead to secure it in the connector because full lead insertion is block by the dislodged spring.Sem spectrum analysis verified the contaminant on the spring is epoxy.A manufacturing anomaly may have occurred that resulted in epoxy contamination of the contact spring.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.

• Brand Name: ASSURITY MRI
• 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: 17033066
• MDR Text Key: 316251403
• Report Number: 2017865-2023-22064
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• 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,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000140982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• 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: RIGHT ATRIAL LEAD.; RIGHT VENTRICULAR LEAD.
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 75 KG