MAUDE Adverse Event Report: MEDTRONIC MILACA, INC.; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5318

Device Problem Display Difficult to Read (1181)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis found that the device did not boot-up.After replacing the printed circuit board, the display screen could not be illuminated and the display content could not be seen clearly.The customer did not accept the price quotation for repair so the device was sent back un-repaired.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned to the manufacturer for inspection.It was analyzed and tested out of specification.There was no patient involvement.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer (Section G): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8442066
• MDR Text Key: 139549790
• Report Number: 2183613-2019-00047
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5318
• Device Catalogue Number: 5318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1