MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CRM-KISTA) ALLURE QUADRA RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3242

Device Problem Programming Issue (3014)

Patient Problem Cardiac Arrest (1762)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a device change out procedure, the patient became asystolic.It was discovered that the pulse generator was programmed to no pacing.The device was reprogrammed and remained implanted.The patient was in good condition after the procedure.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407 ; 4684744043
• MDR Report Key: 5153476
• MDR Text Key: 28408653
• Report Number: 3010215456-2015-29402
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P970013
• 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
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: PM3242
• Device Lot Number: 4565170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• 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): Congenital Anomaly
• Patient Age: 79 YR