MAUDE Adverse Event Report: MEDTRONIC, INC. TWO IS-1 BI LEADS TO IS-1 BI IPG ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER

Model Number 2872

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.There is no indication of the manufacturer of the leads referenced in this article.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The baseline gender/age of the patients represented in the article is male/(b)(6).The date of death is purely an estimate, as there is no indication of specific serial number/patient information.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.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization.Heart rhythm.2016;13(1):183-189.(b)(4).

Event Description

A journal article was reviewed which contained information regarding a parallel y-adapter with unknown manufacturer's leads.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device/manufacturer serial numbers.The article indicated that there were patient deaths identified.Of note, there is no allegation/relatedness between the system and the patients' deaths.The article also indicated that there was loss of bi-ventricular capture, infection and high ventricular thresholds noted.The status of the adapters is unknown.Further follow up did not yet yield any additional information and any additional information pertaining to the cause of death has been requested and not yet received.

• Brand Name: TWO IS-1 BI LEADS TO IS-1 BI IPG ADAPTOR KIT
• Type of Device: ADAPTOR, LEAD, PACEMAKER
• 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: 5495229
• MDR Text Key: 40167792
• Report Number: 2182208-2016-00725
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K982220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2872
• Device Catalogue Number: 2872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2016
• 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: IMPLANTABLE TACHY LEAD
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 00069 YR