MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD PROMOTE QUADRA CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3239-40Q

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems Death (1802); Renal Failure (2041); Sepsis (2067)

Event Date 01/09/2015

Event Type  Death  

Event Description

It was reported the device prematurely reached eri.The device was explanted and replaced.During the procedure, the patient developed atrial tachycardia which progressed to vt, then vf.The physician administered intravenous amiodarone with no response.Three external shocks converted the patient.Subsequently due to the long standing vt/vf, the patient developed renal hypoperfusion leading to acute renal failure.The patient was in hypotension and peritoneal dialysis was initiated.The patient then developed peritonitis, which led to septicemia.While still in the hospital, the patient expired.

Manufacturer Narrative

(b)(4).Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Evaluation description: the reported premature battery depletion was not confirmed in the laboratory.Based on device settings, a longevity calculation was performed and was found to be within expected limits.The device was tested on the bench, and no anomaly was found.(b)(4).

• Brand Name: PROMOTE QUADRA CRT-D, DF-4 CONNECTOR
• 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: 4537292
• MDR Text Key: 5540792
• Report Number: 2938836-2015-01548
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: CD3239-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2013
• 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): Death