MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 ID; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1233-40

Device Problem Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.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

Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and awaiting explant.The patient was stable.

Event Description

New information received notes that following the battery performance alert (bpa) advisory, a bpa was received by the clinician and awaiting explant.The patient had no adverse consequences.

Event Description

New information received notes that following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was removed and replaced.The patient had no adverse consequences.

Manufacturer Narrative

B5 should reflect device explant and replacement.

• Brand Name: FORTIFY VR, U1.6 DF1 ID
• 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: 11263525
• MDR Text Key: 229798403
• Report Number: 2017865-2021-06642
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: CD1233-40
• Device Lot Number: 4134880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0003-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention