MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-LEAD

Device Problems Over-Sensing (1438); Connection Problem (2900)

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

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the right ventricular (rv) lead was not well connected with the implantable pulse generator (ipg).It was also reported there was noise on the rv channel.The rv lead was successfully reconnected with the ipg.The ipg and rv lead 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.

Event Description

Additional information received indicated at follow up check, during a holter testing there were non conducted right atrial (ra) lead p-waves.The physician performed a follow up check but all parameters seems stable.Only amplifying the atrial signal there were isolate double p-wave counting.The sensibility was re-programmed and the double counting disappeared.The ra lead remains in use.

Manufacturer Narrative

The lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC LEAD
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8066770
• MDR Text Key: 127051548
• Report Number: 2182208-2018-02069
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 12/18/2018; 12/18/2018
• Supplement Dates FDA Received: 01/14/2019; 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention