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

Model Number PM3242

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); Dizziness (2194)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported field events of a set screw anomaly and noise were confirmed in the laboratory.Visual inspection identified excess epoxy in the rv ring contact spring.Lead insertion through the spring and movement of the lead and spring broke through the epoxy causing intermittent contact between the spring, ring slot, and the lead.This is consistent with the observation from the field of noise.The cause of the epoxy contaminating the ring contact spring is a manufacturing anomaly.

Event Description

It was reported that a pacemaker dependent patient was called in clinic due to noise observed on the rv lead.Patient was experiencing dizziness and syncope.The patient was recently upgraded to bi-v system and there was no noise prior to the upgrade.Set-screw issue was suspected.Noise was being oversensed and inhibiting the pacing.During procedure, no indication of set screw issue was noted.The lead was reconnected but still there was no clear indication of cause of noise.Lead was replaced but the noise was still evident.Device was also replaced and there was no noise issue with the new device.Physician suspected there is an issue with the device header.Patient¿s condition was stable.

• Brand Name: ALLURE QUADRA
• 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: 6232077
• MDR Text Key: 64127298
• Report Number: 2938836-2017-01607
• 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: Physician
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM3242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR