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

Model Number REDR01

Device Problems False Positive Result (1227); Battery Impedance Issue (2884)

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

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the implantable pulse generator (ipg) reverted to single chamber fixed rate pacing after false elective replacement indicator (eri) was triggered.An abnormal impedance measurement was noted.The device was reprogrammed and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory showed the battery indicator signifying that it is time for device replacement triggered falsely.False elective replacement indicator (eri) triggered on (b)(4) 2017 due to measurement system lock-up.Reset of the device by programmer with updated software cleared the false eri and lock-up condition.Analysis of the device memory indicated the lead impedance data was invalid.Analysis of the device memory indicated the battery measurement was not available.Battery voltage not available due to measurement system lock-up.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIA 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: 7090294
• MDR Text Key: 94077858
• Report Number: 9614453-2017-04021
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

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: 08/28/2013
• Device Model Number: REDR01
• Device Catalogue Number: REDR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2012
• 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 Outcome(s): Required Intervention