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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SYNCRA CRT-P; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC EUROPE SARL SYNCRA CRT-P; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number C2TR01
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/26/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 5076-45, lead, implanted: (b)(6) 2004.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by the patient that they had concerns about the cardiac resynchronization therapy pacemaker (crt-p) longevity.The device remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
SYNCRA CRT-P
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH  1131
MDR Report Key10809832
Report Number9614453-2020-03613
Device Sequence Number3500630
Product Code NVZ
UDI-Device Identifier00613994753304
UDI-Public00613994753304
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P010015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/28/2015
Device Model NumberC2TR01
Device Catalogue NumberC2TR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/26/2020
Initial Report FDA Received Date11/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
407652 LEAD, 419688 LEAD
Patient Age75 YR
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