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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADSR06
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/26/2018
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 patient experienced infection.The implantable pulse generator (ipg) and right ventricular (rv) lead were explanted and later replaced with a leadless implantable pulse generator (ipg).No further patient complications have been reported as a result of this event.
 
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Brand Name
ADAPTA
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 Key10276352
Report Number3004209178-2020-12212
Device Sequence Number811839
Product Code NVZ
UDI-Device Identifier00613994222190
UDI-Public00613994222190
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P980035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/15/2020
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 Date09/14/2014
Device Model NumberADSR06
Device Catalogue NumberADSR06
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2020
Initial Report FDA Received Date07/15/2020
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
402358 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
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