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

Model Number 5437

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis summary: at analysis it was noted that the connector sleeve was missing.All continuity tests were ok and no intermittent or shorted connections were found.If information is provided in the future, a supplemental report will be issued.

Event Description

The cable was returned with no information and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• 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: 7953599
• MDR Text Key: 123305498
• Report Number: 2182208-2018-01830
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5437
• Device Catalogue Number: 5437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/10/2018
• 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