MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

Device Problem Misconnection (1399)

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

Event Date 08/17/2018

Event Type  malfunction  

Event Description

Related manufacturer reference numbers: 2017865-2018-12748, 2938836-2018-10101. During an implant procedure, there was decreased r-wave sensing amplitude noted on the device; therefore, the physician attempted to disconnect the leads to remeasure the sensing value, but there was difficulty loosening the right atrial (ra) and right ventricular (rv) leads from the header of the device. The device and both ra and rv leads were explanted and replaced to resolve this event. The patient was stable.

Manufacturer Narrative

The reported event of the doctor being unable to untighten the right atrial (ra)-setscrew was confirmed. Electrical anomaly was not confirmed. The analysis found on ra-setscrew was firmly stuck in its connector blocks and required destructive methods to separate them from the device connectors. Analysis performed using scanning electron microscope confirmed the foreign material found in the connector block threads to be epoxy, which caused the setscrews to become lodged. When the setscrew was tightened on the leads during the implant procedure the epoxy in the threads caused the setscrews to be locked in place which prevented removal of the leads. As a result of these findings, abbott is performing further investigation.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7829665
• MDR Text Key: 118892205
• Report Number: 2017865-2018-12747
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2019
• Device Model Number: PM3262
• Device Lot Number: P000060473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial