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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number SEDR01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/30/2020
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 patient experienced a system infection.The implantable pulse generator (ipg) system was explanted and replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
SENSIA IPG
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10807808
Report Number3004209178-2020-19531
Device Sequence Number3526172
Product Code NVZ
UDI-Device Identifier00613994177957
UDI-Public00613994177957
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
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? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date03/14/2010
Device Model NumberSEDR01
Device Catalogue NumberSEDR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/16/2020
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
5076-52 LEAD, 5568-45 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age84 YR
Patient Weight59
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