MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ZEPHYR XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5826

Device Problems Device Damaged Prior to Use (2284); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

Prior to implant, it was noted that the screw at the header of the device was damaged.The device did not come in contact with the patient.The patient was in stable condition.

Manufacturer Narrative

The device was received for investigation and visual inspection confirmed a setscrew problem had occurred.The v-septum was partially torn out of the septum cavity.The helix tip of the returned torque wrench was bent at an angle.The user most likely continued to pull the wrench down at an angle while tightening the setscrew as well as during the removal of the wrench which partially tore the septum out of the cavity.The setscrew and setscrew inset were normal and were not stripped.No device anomalies were noted.The problem and damage to the device and torque wrench were related to the user's use of the torque wrench.

• Brand Name: ZEPHYR XL DR
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6533552
• MDR Text Key: 74044501
• Report Number: 2017865-2017-02795
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 5826
• Device Lot Number: P000015180
• Other Device ID Number: 05414734501620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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