MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5356

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2938836-2020-03094.It was reported that the patient presented for a procedure.During the surgery, the pacemaker's atrial interface was loose and the lead could not be connected properly.The ventricular lead could not be fixed into the myocardium.The lead and device were not used and replaced.The patient was stable.

Manufacturer Narrative

The reported complaint of failure to connect was confirmed.Analysis of the header showed both setscrews had been completely backed out of the connector block.Visual inspection found that atrial setscrew threads were damaged, which prevented setscrew to be properly tighten, and this is consistent with user error.The device was received in normal mode.Analysis performed including electrical, mechanical and environmental stress testing indicated the device exhibited normal characteristics.The device battery voltage is normal and above eri level, and the pacing output was stable and normal throughout the entire tests.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.Additional information: d10.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10041624
• MDR Text Key: 190477731
• Report Number: 2938836-2020-03093
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: 11/30/2020
• Device Model Number: 5356
• Device Catalogue Number: 5356
• Device Lot Number: P000081685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/10/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL ST
• Patient Age: 65 YR
• Patient Weight: 65