MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PROMOTE Q CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3221-36

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2017

Event Type  Injury  

Event Description

The device was explanted due to the elective replacement indicator (eri) alert.Further review suggests that it was not premature eri but an overestimation of the battery longevity by the programmer.The device was replaced and the patient was in stable condition.

Manufacturer Narrative

Upon receipt, the device was interrogated with a programmer and the device image and print outs were obtained.Visual inspection revealed no anomalies besides minor scratches on the can.Interrogation of the device revealed the device was at end of service (eos) and multiple alerts for battery depletion were noted on the printouts including an alert for a charge time limit reached due to low battery voltage.A longevity calculation was performed and the device was found to be not within the estimated longevity and the time period between elective replacement indicator (eri) and eos was shorter than expected.Bench testing including impedance, sensing, and pacing output measurements revealed no anomalies.The device was cut open and the battery was sent to the manufacturer for further analysis, where no anomalies were found.The reported event of premature depletion was confirmed, however, the root cause could not be conclusively determined.

• Brand Name: PROMOTE Q CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6560062
• MDR Text Key: 74927864
• Report Number: 2938836-2017-23400
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: CD3221-36
• Device Lot Number: 3059941
• Other Device ID Number: 05414734503068
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 04/11/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR