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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SOLARA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR03
Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Mechanical Problem (1384); Over-Sensing (1438)
Patient Problem Dizziness (2194)
Event Date 09/19/2018
Event Type  Injury  
Manufacturer Narrative
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) was measuring high and undefined impedance on the right ventricular channel due to a loose set screw. This resulted in a polarity switch. Noise was also sensed during arm movement. The patient reportedly experienced non-specific symptoms and felt pre-syncopal. The pocket was re-opened and the set screw was found to not be tightened at all. The screw was secured and the device remains in use. No further patient complications have been reported as a result of this event.
 
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 the impedance of the right ventricular pacing lead was beyond the expected upper range. Analysis of the device memory indicated oversensing due to noise. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSOLARA 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 Key7975817
MDR Text Key124066520
Report Number3004209178-2018-23297
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00643169735682
UDI-Public00643169735682
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2020
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
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 Received10/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2018
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: 10/17/2018 Patient Sequence Number: 1
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