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

Model Number 37712

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date inaccurate, only the year is valid.Information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from health care professional (hcp) via a manufacturing representative (rep) regarding a patient with an im plantable neuro stimulator (ins) for failed back surgery syndrome.It was reported that implantable neurostimulator (ins) will not hold charge.He states that he went too long without charging.The representative was waiting for the appointment.The issue has not been resolved at the time of this report.No surgical intervention occurred or planned.Patient is alive with no injury.Additional information was received from family/ friend.It was reported that patient had poor telemetry or no telemetry with recharging, difficulty charging and ins would not take charge.Patient stated could not remember last time they successfully charged 6-8 months ago.Reason for not charging patient said he had not good excuse.Patient reported the last charge session was more than one to three months ago.Patient was redirected to health care professional (hcp) for possible overdischarge.It was also reported that patient charger is not working.No patient symptoms or complications were reported in this event.The rep reported another manufacturing representative would be seeing the patient on (b)(6) 2018.Additional information received from the representative.It was reported that the overdischarge was confirmed and the clinic was planning on rep lacing the battery on (b)(6) 2018.No further complications reported.

• Brand Name: RESTORE ULTRA
• 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: 7554043
• MDR Text Key: 109558905
• Report Number: 3004209178-2018-12159
• Device Sequence Number: 1
• Product Code: LGW
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2010
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Date Device Manufactured: 11/02/2009
• 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
• Patient Age: 69 YR