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U.S. Department of Health and Human Services

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

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IPG MFG SWITZERLAND CONSULTA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
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.
 
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Brand NameCONSULTA CRT-P
Type of DevicePULSE 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 Key5712897
MDR Text Key47087598
Report Number3002807576-2016-00034
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2015
Device Model NumberC3TR01
Device Catalogue NumberC3TR01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2016 Patient Sequence Number: 1
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