MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) IDENTITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5286

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

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

It was reported that the patient presented for an implant.During surgery, the lead couldn't be inserted in the pacemaker.Then the surgeon changed another new pacemaker, and everything was well.The patient was stable.

Manufacturer Narrative

Customer complaint of unable to insert lead and failure to connect was not confirmed.The device was received in normal working conditions with battery voltage near beginning of life level.The device was tested lead insertion on atrium and ventricle chambers and the results were normal with force within normal range.Additionally, visual inspection of the header and connectors found no contamination or foreign material that could contribute to the reported complaint.Electrical and mechanical test performed found no anomaly.Longevity assessment was performed, and the pacer was in the normal range of operation with appropriate remaining longevity.

• Brand Name: IDENTITY ADX XL
• 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: 10593339
• MDR Text Key: 208773186
• Report Number: 2938836-2020-08455
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734006828
• UDI-Public: 05414734006828
• 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: 11/20/2020

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: 12/31/2020
• Device Model Number: 5286
• Device Catalogue Number: 5286
• Device Lot Number: P000083951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR