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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 Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2017
Event Type  malfunction  
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 had an observation relating to the battery longevity estimator. Longevity was unavailable, stating "remaining longevity is re-initializing. Values will be available within 1 week. " 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
It was reported that three days after the implant procedure, the device battery status showed a gray bar and was re-initializing. Consequent of the re-initializing, there were no lead impedance measurement nor capture management measurement available for review, but that this information would be available in one week. It was noted that the day after the procedure when the device was checked, all results were normal. The device remains in use. No patient complications have been reported as a result of this event.
 
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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 Key6925320
MDR Text Key103325917
Report Number3004209178-2017-21229
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2018
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 Received02/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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