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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 08/02/2018
Event Type  Injury  
Manufacturer Narrative
This device was reported as included in the field action. Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action. It is included in the field action in the abundance of caution. 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 two diagnostic resets. Invalid ventricular sensing episode data was also observed. The device 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.
 
Event Description
The patient was brought in a few days later to update the device software.
 
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 that the atrial and ventricular rate histogram data were missing/invalid. Analysis of the device memory indicated the battery measurement was not available. Analysis of the device memory indicated an issue with missing/invalid diagnostic data. If information is provided in the future, a supplemental report will be issued.
 
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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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7823927
MDR Text Key118469124
Report Number3004209178-2018-19351
Device Sequence Number1
Product Code NKE
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
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 Received09/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2413-2018

Patient Treatment Data
Date Received: 08/28/2018 Patient Sequence Number: 1
Treatment
407658 LEAD, 5076-52 LEAD, 459888 LEAD
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