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 Deliver Energy (1211); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/17/2018

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) via a manufacturer representative.It was reported that the patient was attempting to recharge their ins when the stimulation stopped.It was reported that the ins was overdischarged.The patient was unable to charge the ins.The ins could not be interrogated with the clinician programmer, recharger, or patient programmer.A reset was performed and the patient was able to start using the ins.It was reported that the patient was scheduled for replacement surgery on (b)(6)2018.No further complications are 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: 7606460
• MDR Text Key: 111221083
• Report Number: 3004209178-2018-13564
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Date Device Manufactured: 12/14/2011
• 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: 64 YR
• Patient Weight: 61