MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ENSURA DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number EN1DR01

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

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

Event Date 03/21/2017

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 implantable pulse generator (ipg) exhibited premature battery depletion.The ipg remains in use and a replacement procedure is planned.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: evaluation of the save-to-disk reveals a 80 mv voltage drop.No issue with high battery impedance.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the ipg was explanted and replaced.

Manufacturer Narrative

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

• Brand Name: ENSURA DR MRI SURESCAN
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6625374
• MDR Text Key: 77192767
• Report Number: 9614453-2017-02070
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup,Followup
• Report Date: 10/23/2019

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: 05/28/2012
• Device Model Number: EN1DR01
• Device Catalogue Number: EN1DR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 07/11/2017; 10/18/2019
• Supplement Dates FDA Received: 10/06/2017; 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2010
• 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): Hospitalization; Required Intervention