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 Intermittent Continuity (1121); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Respiratory Distress (2045); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 01/01/2015

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

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for non-malignant pain and failed back syndrome - other.It was reported that the patient was having trouble with the implantable neurostimulator (ins) for the past year.Their surgeon had gone out of the business.The patient had an x-ray done in 2015 to figure out what was wrong with the implant.There was shocking and overstimulation reported.The stimulation turned up by itself in the past 4 months and it caused the patient difficulty in breathing and discomfort.If the patient was going to the bathroom, it would make them stop.The stimulation as reported to be set at a 2 but all of a sudden it would go up to 6-10.In order to stop the sensation, the patient had to drop and lay down on their right side.When the patient did this, the sensation went away immediately.The other day that patient tried to lay on their back but the sensation got worse and they felt a shock or jolt.This occurred intermittently.It was reported that it would happen whenever and was not related to position.There were no related falls or traumas reported.The patient did not have a current health care professional (hcp).

Manufacturer Narrative

(b)(4) also apply to this event.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 from the patient indicated that they were having surgery on (b)(6) 2017 to replace their device with a non-rechargeable one.Their issues have not resolved; they have worsened.The patient noted that have pain in their leg, like the device is not working.They are afraid to change their setting because of the jolting and shocking they get.The patient is trying to deal with the pain until their surgery.

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 received from the consumer via a manufacturer representative (rep) indicated that the patient had intermittent zapping from the ins and they wanted a full body mri compatible device.There were no contributing factors.Reprogramming, re-orientation or the battery, impedance checks and x-rays were done.They removed the surgical lead and sensor battery, and replaced with an mri compatible surgical lead and non-rechargable battery.The issue was resolved at the time of the report.The zapping would depend on the patient¿s position and usually happened when they would arch their head back.They were reprogrammed several times and orientation and re-orientation was done with the adaptive stim.The patient also experienced pain at the pocket site when they recharged.The patient had excellent coverage post operatively and was happy about not having to recharge.

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 received from the manufacturing representative indicated that the patient¿s device was explanted on the (b)(6) 2017, and returned to the manufacturer for analysis.The patient recovered without sequela.

Manufacturer Narrative

Anaysis confirmed c100-no anomoly found with device.

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; 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6174820
• MDR Text Key: 62545700
• Report Number: 3004209178-2016-26451
• 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,Followup,Followup,Followup,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2011
• 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: 55 YR