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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. VERSA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number VEDR01
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/29/2020
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 that the implantable pulse generator (ipg) did not exhibit a longevity estimator value.It was reported that the right ventricular (rv) lead exhibited intermittent capture.The device and lead remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
VERSA IPG
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 Key10910201
Report Number3004209178-2020-20702
Device Sequence Number16830454
Product Code NVZ
UDI-Device Identifier00643169708983
UDI-Public00643169708983
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
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/26/2020
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 Date01/14/2019
Device Model NumberVEDR01
Device Catalogue NumberVEDR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2020
Initial Report FDA Received Date11/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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