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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND AZURE; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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IPG MFG SWITZERLAND AZURE; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number W1SR01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/09/2018
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 that the implantable pulse generator (ipg) and right ventricular (rv) lead were explanted due to a pocket infection.The wound was open and draining.No further patient complications have been reported as a result of this event.
 
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Brand Name
AZURE
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
IPG MFG SWITZERLAND
route du molliau 31
tolochenaz 1131
CH  1131
MDR Report Key7565731
Report Number3002807576-2018-00176
Device Sequence Number1979766
Product Code NVZ
UDI-Device Identifier00643169871953
UDI-Public00643169871953
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/04/2018
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 Date04/28/2019
Device Model NumberW1SR01
Device Catalogue NumberW1SR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2018
Initial Report FDA Received Date06/04/2018
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
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age73 YR
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