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 Nerve Damage (1979); Paralysis (1997); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 08/20/2013

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with a neurostimulator for non-malignant pain and other chronic/intract pain (trunk/limbs).It was reported that the patient needed an mri scanned in his spine.The mri scan was related to the device or therapy.The patient stated that he wanted to have the spinal cord stimulator removed because was not helping him anymore.The patient reported that it did okay initially, but then it wouldn't do anything.The patient has nerve damage to the sciatic nerve in his left leg, and that is the only thing that it helped with, but now it's not helping very much.There was a loss of therapeutic effect and the patient stated that the spinal cord stimulator helped for about a year after implant.The patient stated not only that, but it made it so he couldn't urinate.The patient stated that he doesn't have soft discs, "it's all hard like a brick so once its start going, that's it." the spinal cord stimulator was implanted despite knowing that.The patient is currently taking morphine for his pain.The patient reported that he had an episode of paralysis for 3 hours on the floor and that he had to go to the emergency room in (b)(6) 2016.The patient reported that if he cannot have an mri, he was going to have a ct scan, but he didn't see how they were going to be able to see "a bulge" on a ct scan.The patient reported that he has told his health care provider that he would like to have the system explanted; however there is no planned surgery for the system removal.

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

Additional information was received from the patient that reported that he met with the manufacturer representative about 2 months prior to when the additional information was received to reprogram his settings because the stimulation was causing the patient urinary retention and he couldn't go to the bathroom starting in 2014.The manufacturer representative changed the settings and the patient was using it on a lower setting and is able to go to the bathroom.The patient's medical history includes preexisting sciatic pain due to an issue with a botched surgery.

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: 5554688
• MDR Text Key: 42071306
• Report Number: 3004209178-2016-06294
• 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,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Date Device Manufactured: 07/19/2012
• 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: 00012 MO