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U.S. Department of Health and Human Services

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

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MEDTRONIC EUROPE SARL PERCEPTA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR01
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 4968-35 lead (x2), implanted: (b)(6) 2012. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the right atrial (ra) lead exhibited noise due to possible fracture. The lead was capped and replaced. Noise was subsequently observed on the right ventricular (rv) lead later that day due to possible fracture. The patient was taken back to the operating room the next day. The physician had difficulty unscrewing and rescrewing the rv setscrew back into the cardiac resynchronization therapy pacemaker (crt-p) header. Once the lead was thought to be secured, the noise was no longer present. The lead had been tested with an analyzer and via manual manipulation and all electrical measurements were appropriate. The patient was kept overnight for observation and the noise was observed again on the rv lead the following morning. The lead was then capped and replaced. The crt-p was explanted and replaced due to the header issues the day before. No patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA CRT-P MRI SURESCAN
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10480626
MDR Text Key205244412
Report Number9614453-2020-02692
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169891401
UDI-Public00643169891401
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2021
Device Model NumberW1TR01
Device Catalogue NumberW1TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/23/2020
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: 09/01/2020 Patient Sequence Number: 1
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