MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	ADSR01
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.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 right atrial (ra) lead was capped as the patient progressed to chronic atrial fibrillation and not due to a performance issue.No patient complications have been reported as a result of this event.2024-01-09, it was further reported that there was no performance issues with the lead.2024-06-24: it was further reported that the implantable pulse generator (ipg) exhibited a false low impedance warning.The ipg was explanted and replaced.
Additional Manufacturer Narrative
Correction : event description updated product analysis #(b)(4) / wed jul 03 2024 08:02:51 gmt-0500 central daylight time analysis summary for pe#: (b)(4) analysis transaction id#: (b)(4) model#: adsr01 serial/lot#: (b)(6) the complaint was related to a testable/quantifiable product specification, so the device could be tested explicitly related to the complaint.Analysis of the returned device included review of the data recorded by the device while it was in use, and visual inspection.The device was tested for functional performance: longevity calculation was performed using implant duration, device use-conditions, and settings history (when available) to calculate nominal expected service life.Analysis showed the device performed within specifications.The device did not contribute to the reported complaint.The specific analysis finding is listed below in the analysis information section.Product disposition: the product was retained in storage after the analysis concluded according to storage guidelines the product may be stored off site.Analysis information -- 2024-07-03 08:04:51 cst pli# 10 product id# adsr01 the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.Continuation of d10: product id 457453, lot# serial# (b)(6), implanted: (b)(6) 2004, explanted: (b)(6)2013.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.
Additional Manufacturer Narrative
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 implantable pulse generator (ipg) exhibited a false low impedance warning.The ipg was explanted and replaced.The right atrial (ra) lead was capped for an unknown reason. no patient complications have been reported as a result of this event.

• 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
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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 ; 7635269277
• MDR Report Key: 19594306
• Report Number: 3004209178-2024-13371
• Device Sequence Number: 20935164
• Product Code: NVZ
• UDI-Device Identifier: 00613994222152
• UDI-Public: 00613994222152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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 Date: 08/14/2014
• Device Model Number: ADSR01
• Device Catalogue Number: ADSR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/03/2024; Not provided
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2013
• 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: "SEE H11...."; 407458 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female