MAUDE Adverse Event Report: MEDTRONIC, INC.; PROGRAMMER, PACEMAKER

Model Number 6177

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when a new box of sterile radiofrequency (rf) head sleeves was opened in the catheterization laboratory, it was noted that the first packet had an elastic band within the packaging.The product was returned for analysis.There was no patient involvement.

Manufacturer Narrative

Product analysis: a sterile sleeve was received in sealed packaging for analysis.A foreign object was noted inside the sealed bag.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 7414952
• MDR Text Key: 105245225
• Report Number: 2182208-2018-00453
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 10681490142653
• UDI-Public: 10681490142653
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: 6177
• Device Catalogue Number: 6177
• Device Lot Number: D0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2017
• 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