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

Model Number 37714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that they had sharp pain in both of their legs like being zapped but their stimulation was off.These issues started about 2 weeks prior to the report.The patient's stimulation was intended for their lower back.It was also noted that the patient would get migraine headaches.They had contacted their doctor to request nerve blocks but they were redirected to a chiropractor.The chiropractor would only focus on the patient's neck area.It was noted that when the patient's stimulation was on their whole body was worse.The patient was lying down at the time of the report because they weren't feeling well.There were no falls or trauma related to this event and the stimulation issues were not related to positional movement.The patient later reported that she would see the doctor with a manufacturing representative (rep) at an appointment scheduled for (b)(6).The patient did not know the circumstances that led the issues.The patient was staying home and lying down.The patient had a doctor that went away so she did not have a doctor a while to check.Steps taken to resolve the issue included the patient taking her medications until the appointment on (b)(6), and resting because it was also giving her headaches.The patient mentioned being in 2 hospitals, one for 2 days.They thought the "back pain was bring the left side one.".

Manufacturer Narrative

Corrected information: sex, date of birth.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: 5885900
• MDR Text Key: 52419357
• Report Number: 3004209178-2016-17121
• 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: 08/18/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• 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: 07/25/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: 07/25/2016
• Supplement Dates FDA Received: 09/25/2017
• Date Device Manufactured: 04/09/2013
• 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 Outcome(s): Hospitalization
• Patient Age: 55 YR