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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/26/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported the implantable pulse generator (ipg) system was explanted due to an infection around the mitral valve.A leadless pacemaker was inserted as the patient was pacemaker dependent.No further 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 Key7455103
Report Number3004209178-2018-08708
Device Sequence Number1372922
Product Code NVZ
UDI-Device Identifier00643169474277
UDI-Public00643169474277
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date11/14/2017
Device Model NumberVEDR01
Device Catalogue NumberVEDR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/26/2018
Initial Report FDA Received Date04/24/2018
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
407658 LEAD, 407652 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age82 YR
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