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

Model Number 37714

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330); Electric Shock (2554)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Product id 3487a-56, lot# va06 msb, product id 3487a-56, lot# va0765m.Event date is approximate; month and year valid.(b)(4).

Event Description

Information received from a healthcare provider (hcp) for a clinical study reported that the patient experienced positional loss of stimulation paresthesia with lumbar flexion.No actions were taken and the event was ongoing.The event was due to programming.A week later, the manufacturing representative reported high impedances during impedance test which showed all seemed to be within a normal range except 0 and 1 combination which showed 34,537 ohms.On (b)(6) 2016, one electrode was >40,000 ohms.The patient did not experience symptoms when the device was off.When the patient got in a position today, the patient felt a shocking sensation at peripheral lead site.It was noted the event occurred in (b)(6) 2016.The patient's issue was with group c, which is the main group.Group c was turned on today and as soon as it was on, the patient reported shocking.The amplitude was turned down from 5.0 volts (v) to 0.0v and then up to 3.0v; stimulation was felt but then the patient got in a specific position and felt like they were being shocked again in the same location.Group c was used all the time but 4 months ago the patient could not use it anymore because it was very uncomfortable.Nearly two weeks later, the hcp reported adverse stimulation, episodic shocking sensation with certain movements, so the device was reprogrammed on (b)(6) 2016.Imaging was performed on (b)(6) 2016 showing no abnormalities.Medical history included spinal pain.Stroke occurred in (b)(6) 2016 but there was no clear allegation event was device related.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that interventions included reprogramming.The patient reported episodic shocking sensation with certain movement in the lumbar peripheral neuroelectrodes.The device was interrogated and one electrode was too high out of range with impedances greater than 40,000 ohms.Imaging showed migration of peripheral leads.

Event Description

Additional information was received from the manufacturer representative that there would be a revision due to a shocking sensation.Impedance measurements were not taken.The caller required component compatibility information for the lead extension.It was unknown when the shocking occurred.The manufacturer representative did not have further information regarding the situation at the time of the call.

Manufacturer Narrative

Information references the main component of the system and other applicable components are : product id: 3487a-56, lot# va06msb, product type: lead.Product id: 3487a-56, lot# va0765m, product type: lead.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that interventions included repositioning the leads.Interventions included reprogramming sessions.The outcome was resolved without sequelae.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that interventions included reprogramming on (b)(6) 2016.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that interventions included reprogramming the implantable neurostimulator (ins) on (b)(6) 2016.

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 healthcare professional (hcp) of a clinical study reported that interventions included explanting and replacing the lead on (b)(6) 2017.Interventions included reprogramming the device on (b)(6) 2017.

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 healthcare professional (hcp) of a clinical study reported that the outcome was resolved without sequeale.

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, IMPLANTED (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: 5966414
• MDR Text Key: 55272193
• Report Number: 3004209178-2016-19343
• Device Sequence Number: 1
• Product Code: GZB
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2017

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?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; 03/29/2017
• Supplement Dates FDA Received: 10/20/2016; 11/02/2016; 12/05/2016; 12/19/2016; 01/17/2017; 02/06/2017; 04/17/2017; 09/25/2017
• Date Device Manufactured: 03/04/2013
• 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): Required Intervention
• Patient Age: 53 YR