MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	ADDR01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient experienced a fall with malaise and implantable pulse generator (ipg) site swelling, fever, confusion, hypertension and fluid in the ipg pocket infection.The patient further experienced sepsis due to methicillin-sensitive staphylococcus aureus endocarditis.The patient was transferred to intensive care unit (icu) and medication was administered.The ipg system was explanted and fluid was drained.The patient was transiently hypotensive and a transesophageal echocardiogram revealed mitral valve vegetation.The patient also had trace left lower extremity edema.The patient is a participant in the post approval clinical surveillance product surveillance registry.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction h11: the initial reported event of [infection/erosion] was submitted via an alternative summary report.As the summary report has been revoked, this new information is therefore being submitted via a 30 day report medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ADAPTA
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24019604
• Report Number: 3004209178-2026-00411
• Device Sequence Number: 18439446
• Product Code: NVZ
• UDI-Device Identifier: 00643169441873
• UDI-Public: (01)00643169441873(17)180728
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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 Date: 07/28/2018
• Device Model Number: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 383069 LEAD, 383059 LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White