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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR01
Device Problems Unable to Obtain Readings (1516); Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: vamf3838c200tu stent graft (x2), implanted: (b)(6) 2016. Vamf3838c150tu stent graft, implanted: (b)(6) 2016. Fr995-29 tissue valve, implanted: (b)(6) 2013. 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 and displayed invalid ventricular sensing episode data. It was recommended to bring the patient in for a device software update. The device remains in use. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
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 that the atrial and ventricular rate histogram data were missing/invalid. Analysis of the device memory indicated an issue with missing/invalid diagnostic data. Analysis of the device memory indicated the battery measurement was not available. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient was brought into the clinic for the recommended reprogramming.
 
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Brand NamePERCEPTA QUAD 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 Key8362597
MDR Text Key136893986
Report Number3004209178-2019-03803
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735644
UDI-Public00643169735644
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,Followup,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2018
Device Model NumberW4TR01
Device Catalogue NumberW4TR01
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 Received02/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
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: 02/22/2019 Patient Sequence Number: 1
Treatment
459888 LEAD, 5076-58 LEAD, 5076-52 LEAD
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