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

Model Number MDT-UNKNOWN

Device Problems Device Inoperable (1663); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 01/01/2014

Event Type  Death  

Event Description

A journal article was reviewed which contained information regarding this lead and device model.Multiple patients, failure modes and multiple adverse events were noted in the article; however, a one to one correlation could not be made with unique device or lead/serial numbers.The article included the following failure modes: malfunction and dislodgments.The article included the following adverse events: death, infection, perforations, pericardial effusions and cardiac tamponade.The status of the devices and leads are unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.This information is based entirely on journal literature.All information provided is included in this report.If additional relevant information is received, a supplemental report will be submitted.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.The date of death is an estimate based on the journal publication date.Referenced article: incidence of lead dislodgement, malfunction and perforation during the first year following device implantation.Neth.Heart j.2014;22(6):286-291.An email was sent to the author requesting additional information, with no reply as of yet.(b)(4).

• 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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4152611
• MDR Text Key: 21526159
• Report Number: 2182208-2014-02504
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-UNKNOWN
• Device Catalogue Number: MDT-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• 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
• Treatment: MDT-LEAD IMPLANT UNK
• Patient Outcome(s): Death