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

Model Number ADDR03

Device Problems Device Expiration Issue (1216); Pacing Problem (1439)

Patient Problem Bradycardia (1751)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.

Event Description

It was reported that the patient presented to the emergency room with symptoms of weakness and felling faint due to bradycardia.A device check indicated that the device had switched to ventricular pacing only due to elective replacement indicator (eri).The patient only had an atrial lead as the ventricular port was plugged at implant; so consequently, the patient now was not being paced at all.The device was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.

Manufacturer Narrative

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

• 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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5859562
• MDR Text Key: 51692608
• Report Number: 3004209178-2016-15968
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2016

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: 04/14/2009
• Device Model Number: ADDR03
• Device Catalogue Number: ADDR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided; 08/23/2016
• Supplement Dates FDA Received: 10/06/2016; 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2120-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR