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

Model Number MDT-LEAD

Device Problems High impedance (1291); High Sensing Threshold (2574); High Capture Threshold (3266)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Initial reporter: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

A law suit alleged that the implantable pulse generator (ipg) was suspected to have become non-functional.The right ventricular (rv) lead impedance and threshold values were high.It was also suspected that the ventricular lead was not connected at implant.The polarity of the lead was switched to unipolar.It was additionally noted that lead trend data showed the right atrial (ra) lead had high threshold.A re-operation procedure was planned.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated atrial pacing capture threshold was elevated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7717776
• MDR Text Key: 114946663
• Report Number: 2182208-2018-01356
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• 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?: No
• Date Manufacturer Received: 08/08/2018
• 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
• Patient Age: 75 YR