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

Model Number PM3242

Device Problem Failure to Capture (1081)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 01/31/2017

Event Type  Injury  

Event Description

It was reported that when the patient presented in clinic after being transferred from another hospital, it was noted that the patient received four inappropriate shocks due to double counting rv pacing depolarization since the device was at maximum output.The previous hospital erased all the egms and there was no record to view.The patient has an icd implanted in the abdomen, and a pacemaker implanted in the left pectoral.Device was reprogrammed by the previous hospital.Analysis of the egms shows likely oversensing of pacing output.It was suspected that the pacemaker is likely tracking a sinus tachycardia, with conducted qrs's seen on the vf episode.The rv output was not capturing but was being sensed by the icd as well as intrinsic qrs.This was leading to diagnosis of vf and delivery of therapy.It was recommended to explant the pacemaker since there is the possibility of increased outputs during bvvi, as well as having two devices is contraindicated.Device was checked and is functioning normal now.Patient is doing fine.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6538030
• MDR Text Key: 74206185
• Report Number: 2938836-2017-23273
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: PM3242
• Device Lot Number: 4795940
• Other Device ID Number: 05414734507912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR