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

Model Number	ADDRL1
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced two hundred and ten pauses over a two week period.In response to the advisory describing the potential for a device circuit error to occur while the device is processing an atrial-sensed event, the implantable pulse generator (ipg) is indicated for exhibiting pauses.It was also noted that the right ventricular (rv) lead exhibited low impedance leading to a polarity switch, and that underpacing and oversensing were observed on a zio patch.It was also noted that the rv lead exhibited a loss of oversensing that led to a lack of pacing and pacing spikes with a loss of output.The electrophysiologist believes that an inner insulation issue was the cause.The ipg and rv lead were removed and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15377456
• Report Number: 3004209178-2022-11481
• Device Sequence Number: 20245848
• Product Code: NVZ
• UDI-Device Identifier: 00643169708709
• UDI-Public: 00643169708709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 04/28/2019
• Device Model Number: ADDRL1
• Device Catalogue Number: ADDRL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2017
• 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: ADDRL1 IPG, 4968-35 LEAD, 4968-35 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 36 KG