FDA.reportPublic FDA data

MAUDE MDR 9908079

MDR report key
9908079
Report number
9614453-2020-01123
Event key
0
Event type
3
Date of event
2020-03-20
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAULA BIXBY
Address
8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CLARIA MRI CRT-D SURESCANDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIOMEDTRONIC EUROPE SARLNIKDTMA2D1DTMA2D1Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

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 SHOWED THE BATTERY IS APPROACHING THE INDICATOR SIGNIFYING THE TIME FOR DEVICE REPLACEMENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT TEN DAYS POST IMPLANT PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION CAUSED BY HIGH THRESHOLD MEASUREMENTS OF LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE LV LEAD SEEM TO INCREASE OR VARIATE SIGNIFICANTLY IN THRESHOLDS. IT WAS ALSO NOTED THAT ANODAL STIMULATION WAS OBSERVED AT LV THRESHOLD PACING WITH HIGH VOLTAGE. DUE TO THE COVID-19 REGULATIONS THE PATIENT WILL NOT BE CALLED IN FOR REPROGRAMMING UNTIL IT IS SAFE. THE DEVICE AND LV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.