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); Unintended Collision (1429); Battery Problem (2885); Charging Problem (2892)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for degenerative disc disease and spinal pain.It was reported the patient was charging too frequently.The patient noted she was initially charging every 4-10 days, then, in the summer of 2015, she had to charge every day or two, and then, around (b)(6) 2015, it would only hold a charge for a few hours.It was noted there was a fall that could have been related to the issue.The patient fell backwards so hard that it knocked her unconscious and when she fell, her implantable neurostimulator (ins) hit the counter.This fall occurred in the summer of 2015.There were no recent unrelated medical procedures, activities, or electromagnetic interference (emi) related to the event.The patient was scheduled to see a new healthcare provider (hcp) on (b)(6) 2016.Symptoms reported included a return of pain in the lower back and left leg.The patient last felt stimulation around (b)(6) 2016 and the last successful charge occurred around (b)(6) 2015.It was suggested to the patient to have her device checked as the patient had not had her device checked at all since the fall occurred.

Manufacturer Narrative

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

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5611945
• MDR Text Key: 43783314
• Report Number: 3004209178-2016-08374
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Date Device Manufactured: 05/08/2012
• 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): Other
• Patient Age: 44 YR