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

Model Number ADDR01

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that the right atrial (ra) lead exhibited undersensing.Also, the implantable pulse generator (ipg) appeared to be under reporting the atrial burden.The atrial burden and cardiac compass don't match the histogram data possibly due to post-modeswitch overdrive pacing (pmop) and collection delay.Reprogramming was discussed and the lead and device remain in use.No patient complications have been reported as a result of this event.

• Brand Name: ADAPTA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5283726
• MDR Text Key: 33482339
• Report Number: 3004209178-2015-24722
• Device Sequence Number: 1
• Product Code: NVZ
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2014
• Device Model Number: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2015
• Initial Date FDA Received: 12/09/2015
• Date Device Manufactured: 10/04/2012
• 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
• Patient Age: 00080 YR