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

Model Number	5376
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Complaint, Ill-Defined (2331)
Date of Event	10/13/2018
Type of Reportable Event	Serious Injury
Additional 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.(b)(4).
Event or Problem Description
It was reported that the patient presented at a hospital on (b)(6) 2018 due to precordial pain.The patient was transferred to a different hospital on (b)(6) 2018 due to her symptoms and history of multiple surgeries to place stents.The patient received an angioplasty procedure on (b)(6) 2018 unrelated to the devices.The next day (b)(6) 2018 the patient had a stoke adams event.A chest x-ray revealed the pacemaker was broken.The patient was stable and received a temporary pacemaker.The implanted pacemaker was deactivated.The patient was scheduled for a pacemaker explant, procedure date (b)(6) 2018.The procedure was lengthy.Testing of the leads revealed failure to capture in the right ventricular lead.The right ventricular lead was turned off.The physician believes the pacemaker case came off from the battery.The pacemaker was replaced and a new right ventricular lead was successfully placed in a different position.The patient was stable following the procedure.
Additional 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.
Additional Manufacturer Narrative
Correction: narrative on previous follow up 2017865-2018-15833 for analysis should have been: "the reported events of damage was not confirmed.Visual examination of the device revealed no damage.Environmental stress testing revealed no anomalies.Further testing found the device battery is still above elective replacement battery levels.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity " not "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.".

• Brand Name: IDENTITY XL DR
• 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: 8001211
• Report Number: 2017865-2018-15833
• Device Sequence Number: 1531211
• Product Code: LWP
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2019

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: 07/31/2009
• Device Model Number: 5376
• Device Lot Number: 0002190757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 01/11/2019
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/13/2018; 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1646T/58, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR