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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number VEDR01
Medical Device Problem Code Pacing Problem (1439)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by a patient's family member that their "device is skipping beats".The implantable pulse generator (ipg) remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
VERSA DR
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key8100334
Report Number3004209178-2018-26134
Device Sequence Number1733795
Product Code NVZ
UDI-Device Identifier00643169474277
UDI-Public00643169474277
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/24/2018
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 Date04/28/2018
Device Model NumberVEDR01
Device Catalogue NumberVEDR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2018
Initial Report FDA Received Date11/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age76 YR
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