MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and non-malignant pain.There was poor communication.The patient reported that they cannot charge their implant and lost connection from the ins to their recharger.They have not used their implant in a long time.Therefore, they have not charged it for over a year.The patient¿s reason for not charging was because they have been a ¿bad boy¿ and did not charge their implant.The patient was redirected to follow up with their healthcare professional (hcp).Additional information was received from the manufacturer representative on 2018-may-22.It was reported the patient states the battery needs a trickle charge.The battery has been off and has not charged in over a year.The patient did not bring his equipment to the appointment with representative.The representative tried to read the ins with the clinician programmer and was unable to read as battery was overdischarged.The patient was advised to make an appointment and bring all his charging equipment.Will attempt to trickle charge.Since this was the second time the battery was overdischarged (per patient) the patient was advised they may not be able to get it started and would need to have it replaced.The issue was not resolved at the time of the reported.Additional information was received from a manufacturer representative regarding the patient on 2018-jun-29.It was reported that the device was overdischarged and was planned to be replaced, but the replacement surgery was not yet scheduled.There were no further complications reported or anticipated.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7655924
• MDR Text Key: 112933810
• Report Number: 3004209178-2018-14808
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

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: Health Professional
• Device Expiration Date: 01/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/02/2018
• Date Device Manufactured: 02/17/2012
• 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