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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. SENSIA IPG; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number SESR01
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/23/2017
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) had premature battery depletion due to the high right ventricular (rv) lead thresholds.The ipg was explanted and replaced and the lead was capped and replaced.No 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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key9232721
Report Number3004209178-2019-20304
Device Sequence Number2388531
Product Code NVZ
UDI-Device Identifier00643169474260
UDI-Public00643169474260
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/24/2019
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 Date11/28/2017
Device Model NumberSESR01
Device Catalogue NumberSESR01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2019
Initial Report FDA Received Date10/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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