MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number MDT-IPG

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Chest Tightness/Pressure (2463)

Event Date 12/24/2019

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 patient experienced premature heartbeat and felt chest tightness.Reprogramming is planned.The implantable pulse generator (ipg) remains in use.No further 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

It was further reported that the patient symptoms were not related to the implantable pulse generator (ipg), and that there were no device malfunctions.

• Brand Name: MEDTRONIC IPG
• Type of Device: PULSE GENERATOR, PERMANENT, 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9596077
• MDR Text Key: 175211459
• Report Number: 2182208-2020-00090
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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-IPG
• Device Catalogue Number: MDT-IPG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/27/2020
• 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): Required Intervention
• Patient Age: 84 YR