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

Model Number ADDR01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 10/19/2020

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 died.Follow-up was attempted to obtain the relevant information; however, no additional details are available at this time.This event is being conservatively reported in an abundance of caution in response to the advisory describing the potential for device circuit error to occur while the device is processing an atrial-sensed episode.

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Upon secondary review the reported event of the patient death where follow-up was attempted to obtain the relevant information; however, no additional details are available at this time.This event is being conservatively reported in an abundance of caution in response to the advisory describing the potential for device circuit error to occur while the device is processing an atrial-sensed episode did not cause or contribute to death or serious injury and is not likely to do so if it were to recur.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further noted upon review that this device is not related to an advisory for potential for device circuit error to occur while the device is processing an atrial-sensed episode.

• 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
• 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: 10821528
• MDR Text Key: 215863864
• Report Number: 3004209178-2020-19719
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994222046
• UDI-Public: 00613994222046
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2020

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: 07/14/2015
• Device Model Number: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/11/2020; 11/20/2020; 11/23/2020
• Supplement Dates FDA Received: 11/13/2020; 11/27/2020; 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 94 YR