MAUDE Adverse Event Report: MEDTRONIC, INC. LEAD EXTENDER KIT; ADAPTOR, LEAD, PACEMAKER

Model Number 6984M

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260)

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

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 200h18 tissue valve, implanted (b)(6) 2014; 4965-15 lead, implanted (b)(6) 2011; 200h14 tissue valve, implanted: (b)(6) 2011.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the lead extender was fractured/ loose resulting in the right atrial (ra) lead not functioning correctly.The lead was capped.No patient complications have been reported as a result of this event.

• Brand Name: LEAD EXTENDER KIT
• Type of Device: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8715582
• MDR Text Key: 148522609
• Report Number: 2182208-2019-01110
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00681490153621
• UDI-Public: 00681490153621
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915724
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 6984M
• Device Catalogue Number: 6984M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2019
• Date Device Manufactured: 03/19/2012
• 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: 407652 LEAD, ADDRS1 IPG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR