MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AZURE; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W1SR01

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Mechanical Problem (1384); Loss of Threshold (1633); High Capture Threshold (3266)

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

Event Date 06/17/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use the right ventricular (rv) lead exhibited high thresholds, and high impedance.During the rv lead revision procedure, x-ray showed that the lead pin was advanced into the implantable pulse generator (ipg) header but during the rv lead revision procedure the lead pulled right out.The ipg) set screw was not tight.Analyzer showed normal values of the rv lead.An ipg set screw issue was noted, and the set screw was tightened down.The rv lead was secured and pocket closed.The rv lead and ipg remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AZURE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7691580
• MDR Text Key: 114103440
• Report Number: 3004209178-2018-15864
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169634626
• UDI-Public: 00643169634626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• 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,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2019
• Device Model Number: W1SR01
• Device Catalogue Number: W1SR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/28/2018
• 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: 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 94 YR