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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR04
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during an implant procedure, there was a set screw issue with the cardiac resynchronization therapy pacemaker (crt-p)'s right ventricular port. The physician had difficulty removing the wrench from the set screw after turning it and fixing the lead. The wrench was removed from the set screw with force and the device remains in use. No patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA QUAD 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8110073
MDR Text Key128591099
Report Number9614453-2018-04204
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
Type of Report Initial
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2019
Device Model NumberW4TR04
Device Catalogue NumberW4TR04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/12/2018
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: 11/28/2018 Patient Sequence Number: 1
Treatment
5076-58 LEAD
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