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

Model Number	5286
Medical Device Problem Codes	Failure to Interrogate (1332); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the clinic for a follow-up.During the visit, the patient's pacemaker was unable to be interrogated.The patient was asymptomatic.The physician explanted and replaced the device.The patient was stable throughout.
Additional Manufacturer Narrative
Field complaint of failure to interrogate was confirmed and was due to loss of telemetry.The device was tested on the bench and and no anomalies were noted.The device battery was at eri and electrical testing with external battery was performed and no anomaly was noted.Further electrical testing with external power supply showed loss of telemetry at 2.2v which is consistent with u2 combo ic anomaly.Longevity assessment was performed and device exceeded the projected longevity.
Additional Manufacturer Narrative
Correction: previous report should have g3 date received by manufacturer as (b)(6) 2021.

• Brand Name: IDENTITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11821806
• Report Number: 2017865-2021-17926
• Device Sequence Number: 1061064
• Product Code: DXY
• UDI-Device Identifier: 05414734006828
• UDI-Public: 05414734006828
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2008
• Device Model Number: 5286
• Device Catalogue Number: 5286
• Device Lot Number: 0002172022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 06/28/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/25/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention