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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR04
Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the day following implant, the cardiac resynchronization therapy pacemaker (crt-p) atrial channel setscrew came out of the device. The device was explanted and replaced. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A 3830-69 lead, implanted: (b)(6) 2018. This device was reported as included in the field action. Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action. It is included in the field action in the abundance of caution. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information indicated that during the lead revision procedure, blood got into the header of the device and while the physician was attempting to clean the device, the setscrew came out. The patient is a participant in the post approval clinical surveillance product surveillance registry. No 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.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. The returned device had a loose/detached connector. The returned device had a damaged connector. This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action. The device is no longer included as part of the field action. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePERCEPTA CRTP
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key7666263
MDR Text Key113309446
Report Number9614453-2018-02504
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2019
Device Model NumberW1TR04
Device Catalogue NumberW1TR04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2414-2018

Patient Treatment Data
Date Received: 07/06/2018 Patient Sequence Number: 1
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