MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ADAPTA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDRL1

Device Problems Premature Discharge of Battery (1057); Device Expiration Issue (1216); Pacing Problem (1439)

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

Event Date 08/23/2017

Event Type  malfunction  

Event Description

It was reported that during use the implantable pulse generator (ipg) exhibited pacing problem.It was also reported that the ipg exhibited shortened service life due associated rv lead high threshold.Physician indicated rv lead high threshold due to patient's cardiac muscle condition.Diagnostic testing/troubleshooting performed.Patient did not accept to replace device.The ipg remains 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 EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7093120
• MDR Text Key: 94207358
• Report Number: 9614453-2017-04336
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2017

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: 12/14/2013
• Device Model Number: ADDRL1
• Device Catalogue Number: ADDRL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 12/07/2017
• Date Device Manufactured: 06/16/2012
• 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