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

Model Number ADDR01

Device Problem Protective Measures Problem (3015)

Patient Problem Dyspnea (1816)

Event Date 12/21/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient is deceased.The cause of death is unknown.It was reported that the implantable pulse generator (ipg) exhibited "issues with the alarms" and the patient experienced shortness of breath and "different beats".

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.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.

Event Description

It was further reported that the patient is not deceased.No further patient complications have been reported as a result of this event.

• Brand Name: ADAPTA
• 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
• MDR Report Key: 11145480
• MDR Text Key: 225985279
• Report Number: 3004209178-2021-00464
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994222046
• UDI-Public: 00613994222046
• Combination Product (y/n): N
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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: 11/28/2011
• Device Model Number: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5054-58 LEAD, 559445 LEAD; 5054-58 LEAD, 559445 LEAD.
• Patient Outcome(s): Death
• Patient Age: 67 YR