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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W1TR01
Device Problems Unable to Obtain Readings (1516); Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 419688 lead, implanted: (b)(6) 2018. 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) exhibited an electrical reset, possibly on two occasions. Ventricular sensing episode data also appeared to be invalid. The patient is to be monitored remotely and the device remains in use. No patient complications have been reported as a result of this event.
 
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Brand NamePERCEPTA CRTP
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8568820
MDR Text Key143685901
Report Number3004209178-2019-08649
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
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 Received04/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/03/2017
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: 05/01/2019 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-45 LEAD
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