MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDDRA500Q

Device Problem Delayed Charge Time (2586)

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

Event Type  malfunction  

Event Description

It was reported that during device preparation prior to implant, the implantable cardioverter defibrillator was exhibiting slow charge time.It was elected to not implant the device.There was no patient involvement.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: GALLANT DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11686538
• MDR Text Key: 246050642
• Report Number: 2017865-2021-15480
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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: 09/30/2022
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000078897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1