MAUDE Adverse Event Report: MEDTRONIC, INC. VITATRON DA+ T-SERIES SR; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number T20A1U

Device Problems Failure to Interrogate (1332); Reset Problem (3019)

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

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use the implantable pulse generator (ipg) was unable to be interrogated.It was also reported that a electrical reset of ipg was unable to perform by physician.Diagnostic testing/troubleshooting performed.The ipg remains in use, and explant planned for a later time.No patient complications have been reported as a result of this event.

• Brand Name: VITATRON DA+ T-SERIES SR
• 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: 7091547
• MDR Text Key: 94916873
• Report Number: 2182208-2017-01963
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P990001
• 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
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2006
• Device Model Number: T20A1U
• Device Catalogue Number: T20A1U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Date Device Manufactured: 02/16/2005
• 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: 86 YR