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); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain and post lumbar laminectomy syndrome.It was reported that the patient (pt) ins stopped working.Pt clarified this by indicating that the stimulation stopped and the ins will not charge.Pt tried to charge the ins about two weeks ago, but was unable to start a normal recharge session.Pt stated she last charged the ins over a month ago.It was mentioned that prior to this issue, it was really hard to charge the ins.It was stated that it would take up to two days to charge the ins because the recharger would get too hot and then shut off.The pt was transferred to repair and the antenna was replaced.No further complications were reported.

Manufacturer Narrative

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

Event Description

Information was received from the patient who responded back from a follow up letter sent to them.The patient reported that a replacement was sent to them which resolved their issues.

• 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: 7530227
• MDR Text Key: 108998124
• Report Number: 3004209178-2018-11396
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: 01/28/2014
• 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: 05/17/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 06/28/2018
• Date Device Manufactured: 03/12/2013
• 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 Age: 71 YR