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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR04
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/03/2019
Event Type  malfunction  
Manufacturer Narrative
Product event summary : the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a software error.Analysis of the device memory indicated a false alert for lead impedance out of range.Analysis of the device memory indicated that the atrial and ventricular rate histogram data was missing/invalid.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) had a partial power on reset, which caused the rate histograms and percentage pacing data to be cleared, but the device continued to operate as programmed and began collecting new data automatically.A device update, delivered via in-clinic interrogation, was recommended by the manufacturer and the device remains in use.It was also reported that the left ventricular lead impedance had one low pacing impedance measurement.It was noted to have been trending low, but stable.The lead remains in use.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.
 
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Brand Name
PERCEPTA QUAD CRT-P MRI SURESCAN
Type of Device
PULSE 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8826024
MDR Text Key152183876
Report Number9614453-2019-02519
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/25/2019
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 Date08/28/2019
Device Model NumberW4TR04
Device Catalogue NumberW4TR04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2019
Initial Date FDA Received07/25/2019
Supplement Dates Manufacturer Received07/25/2019
Supplement Dates FDA Received07/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2415-2018
Patient Sequence Number1
Treatment
4298-88 LEAD
Patient Outcome(s) Required Intervention;
Patient Age80 YR
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