MAUDE Adverse Event Report: IPG MFG SWITZERLAND CONSULTA CRT-P; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number C3TR01

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Cardiac Arrest (1762)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that as the atrial lead and left ventricular (lv) lead were removed from the relevant device body, pacing failure of the right ventricle (rv) suddenly occurred.Then, the rv lead was immediately removed from the relevant device body and then switched to an external pulse generator (epg).Since the patient did not have an intrinsic pulse this resulted in cardiac arrest for 30 seconds.The programmer screen suddenly switched several times.It eventually switched to the emergency mode screen.According to the staff of the operating room, the emergency button on the programmer was touched and programmed though the relevant pacemaker was outside of the patient's body.Then it seemed to be led to unipolar setting and the patient went into cardiac arrest.However the programming operator stated that they had no recollection of touching the emergency button.It was requested that the device and programmer be analyzed so both products were returned for analysis.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONSULTA CRT-P
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5712897
• MDR Text Key: 47087598
• Report Number: 3002807576-2016-00034
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2015
• Device Model Number: C3TR01
• Device Catalogue Number: C3TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: 04/22/2016
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR