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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SERENA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL SERENA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR05
Device Problem Misconnection (1399)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: siello lead implanted: unknown, siello s lead, implanted: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that about two weeks after implant, the left ventricular (lv) lead exhibited high and undefined pacing impedance. The lv lead also exhibited an increase in pacing threshold and then later a loss of pacing capture. It was noted that the patient felt a reduction in exercise capacity in the last days, but no other symptoms. On the day of the system revision, pre-procedure fluoroscopy indicated that the connector pin was probably not fully seated but still within the lv connection. After opening the pocket, the physician confirmed a device and lead connection issue. The lead came out of the connector head with a light pull without loosening the setscrew. The lv lead was re-inserted, the setscrew was tightened, and a device check indicated impedances and thresholds as those measured at implant. The device and lv lead remain in use. The patient is a participant in the attain stability quad clinical study. No patient complications have been reported as a result of this event.
 
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Brand NameSERENA QUAD CRTP
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7091721
MDR Text Key94146767
Report Number9614453-2017-04192
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2018
Device Model NumberW4TR05
Device Catalogue NumberW4TR05
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 Received10/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/12/2017
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: 12/07/2017 Patient Sequence Number: 1
Treatment
479888 LEAD, 459888 LEAD
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