MAUDE Adverse Event Report: MEDTRONIC, INC. TRANSFORM

Model Number 4710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 02/27/2018

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 implantable pulse generator (ipg) system was explanted due to infection.The device eroded from the pocket and was visible at a break in the skin.Cultures were taken.Antibiotic treatment was necessary.No further patient complications have been reported as a result of this event.

• Brand Name: TRANSFORM
• 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: 7415543
• MDR Text Key: 105098491
• Report Number: 2182208-2018-00466
• Device Sequence Number: 1
• Product Code: LDK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: G860225
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• Device Model Number: 4710
• Device Catalogue Number: 4710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Date Device Manufactured: 05/16/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99