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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 Failure to Interrogate (1332); Pacing Problem (1439)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2019
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) could not be interrogated and did not respond to a magnet. 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 device was later confirmed to have been explanted and replaced.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The crt-p's programmed lower rate was seventy beats per minute but the patient's heart rate was in the fifties. The device is scheduled for replacement.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. The actual longevity was less than 80% of the 99. 9% longevity limit. The device was not fully functional. Hybrid analysis confirmed the no-output and no-telemetry condition and was shown to be due to a depleted battery. However, no high current drain was observed. During 7 additional days of temperature and humidity stress, no additional current drain or other failure symptoms were observed. Battery analysis found no evidence of an internal mechanism for premature depletion was found during destructive analysis. Two areas of errantly located cathode material were found, but they did not create an internal shorting path or affect the performance of the battery. Analysis of the returned device was inconclusive. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8382255
MDR Text Key137560168
Report Number3004209178-2019-04307
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,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2019
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2018
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: 03/01/2019 Patient Sequence Number: 1
Treatment
5076-58 LEAD, 5076-52 LEAD, 459888 LEAD
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