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

Model Number CD3215-36

Device Problems False Alarm (1013); Device Operates Differently Than Expected (2913)

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

Event Date 03/05/2015

Event Type  malfunction  

Event Description

It was reported that the patient presented to the emergency room after receiving a patient notifier.Device interrogation showed the alert, but no reason was given for the alert.Review of the alerts page showed hv lead impedance out of range.Review of session records revealed no out of range impedances.However, two postponed hvli measurements were noted.The alert was suspected to be false.The notifier was turned back on and the patient was discharged.

Manufacturer Narrative

(b)(4).

• Brand Name: PROMOTE ACCEL CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4760341
• MDR Text Key: 5789268
• Report Number: 2938836-2015-04723
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial

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: 08/31/2010
• Device Model Number: CD3215-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2009
• 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 Age: 79 YR