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

Model Number VEDR01

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Sleep Dysfunction (2517); Syncope/Fainting (4411)

Event Date 02/14/2023

Event Type  Injury  

Event Description

It was reported that the patient had difficultly sleeping and experienced syncope.It was also reported that the patient went non-responsive and asystole for twenty seconds while in emergency care.The implantable pulse generator (ipg) exhibited pacing issues and noise.The right atrial (ra) and right ventricular (rv) leads exhibited high out of range (oor) impedance values, underwent a polarity switch and fractured.It was also reported that the ra lead exhibited noise and that the rv lead exhibited oversensing.Initially a temporary lead was implanted via the internal jugular for backup pacing.Both the ra and rv leads were capped and replaced.The ipg was explanted and replaced. no further patient complications have been reported as a result of this event.

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.

• Brand Name: VERSA IPG
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16500709
• MDR Text Key: 310851593
• Report Number: 3004209178-2023-03120
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994222114
• UDI-Public: 00613994222114
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2014
• Device Model Number: VEDR01
• Device Catalogue Number: VEDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/08/2023
• Date Device Manufactured: 08/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-58 LEAD: 5076-52 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Male
• Patient Weight: 119 KG