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

Model Number PM2240

Device Problem Difficult to Remove (1528)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

Related manufacturer report #: 2017865-2024-01931; 2017865-2024-01933 it was reported that the patient was asymptomatic to inhibited paced beats but was dependent on the pacemaker for normal function.The patient was brought into clinic (b)(6) 2024 for a right ventricular (rv) lead revision due to observed dropped pacing beats as a result of noise and oversensing, however the subclavian vein was occluded, and the patient was set for extraction (b)(6) 2024.During the extraction procedure, the right atrial (ra) lead could not be unscrewed from the generator.The ra lead was therefore cut and explanted.The rv lead was noted by the physician to be fractured during the extraction procedure.The generator was replaced due to being close to the normal elective replacement indicator (eri).The patient was stable before, throughout, and post procedure.

Manufacturer Narrative

The reported event of cannot removed the atrial lead from the header was confirmed.Analysis revealed this device has the original scalable brady pacemaker (sbp) header design, which is known to have lead insertion and removal difficulties.The header design is what caused the atrial lead to become stuck and un-removeable from the header.Also, the ventricular lead was pulled apart by the physician while trying to remove it out of the connector.This shows the high abnormal force needed to remove leads from the connectors of the original sbp header design.Actions have already been taken to prevent reoccurrence.A header re-design has been implemented to correct this issue.

Manufacturer Narrative

Correction: section h6: health effect - impact code corrected to "4632 - prolonged surgery".

Event Description

Information received reconfirms that though the pacemaker had reached the elective replacement indicator (eri), there was a suspected issue with the pacemaker set screw such that the right atrial lead could not be unscrewed from the generator.

• Brand Name: ASSURITY RF DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18603199
• MDR Text Key: 334075180
• Report Number: 2017865-2024-03261
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• 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,Followup
• Report Date: 03/29/2024

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: 03/31/2016
• Device Model Number: PM2240
• Device Lot Number: 4780653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/29/2024; Not provided
• Supplement Dates FDA Received: 02/15/2024; 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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 Age: 83 YR
• Patient Sex: Male