MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; IMPLANTABLE PULSE GENERATOR

Model Number AZDR01

Device Problems Device Inoperable (1663); Capturing Problem (2891)

Patient Problem No Code Available (3191)

Event Date 09/25/2016

Event Type  Injury  

Event Description

Pt underwent dddr pacemaker insertion on (b)(6) 2016, post-op the continued to be symptomatic and pacemaker was noted to have poor capture.Suspected lead misplacement or lead failure and required return to operating room for pacemaker revision.We learned that the pacemaker generator itself malfunctioned.

• Brand Name: MEDTRONIC
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5993330
• MDR Text Key: 56368455
• Report Number: MW5065128
• Device Sequence Number: 1
• Product Code: NVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AZDR01
• Device Lot Number: PNJ4298247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR