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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC, INC. 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 Insufficient Information (4580)
Date of Event 09/10/2019
Type of Reportable Event Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by the patient's spouse that the patient is deceased.The reporter stated that the "implantable pulse generator (ipg) was so messed up" and that the patient was "supposed to get a new one but they didn't make it".Additional information related to the cause of death was requested and not received.
 
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Brand Name
SENSIA IPG
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key12704879
Report Number2182208-2021-04247
Device Sequence Number19209251
Product Code NVZ
UDI-Device Identifier00613994177957
UDI-Public00613994177957
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/27/2021
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date11/14/2008
Device Model NumberSEDR01
Device Catalogue NumberSEDR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2021
Initial Report FDA Received Date10/27/2021
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
4092-52 LEAD, 5076-45 LEAD
Outcome Attributed to Adverse Event Death;
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