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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRT-P MRI SURESCAN PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 04/07/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 383069, lead, implanted: (b)(6) 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced a hematoma less than a month after implant of the cardiac resynchronization therapy pacemaker (crt-p). The hematoma was evacuated. The crt-p remains in use. No further 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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10003362
MDR Text Key189161890
Report Number3004209178-2020-07763
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735637
UDI-Public00643169735637
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 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2021
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 Received04/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/02/2019
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: 04/27/2020 Patient Sequence Number: 1
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