MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Seizures, Grand-Mal (2168); Therapeutic Response, Decreased (2271)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3587a25, lot# n248803, implanted: (b)(6) 2012, product type: lead.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 manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that on (b)(6) 2017 the patient had a lead revision of a motor cortex lead to achieve better pain relief.It was stated that the case went well with no issues; however, the hospital called the manufacturer representative later that night to inquire whether stimulation was on because the patient was experiencing seizures.It was noted that stimulation was not on when the manufacturer representative left the operating room, and they were not aware whether it was turned on after they left.It was noted that there was no issues with any product.Additional information later received from a consumer reported that the patient had a loss of therapy and return of symptoms on the left side of their face in 2015.They experienced severe pain on the left side of their face, however they didn't consider that the implant wasn't working so they worked with their pain healthcare professional for the pain and also received nerve blocks which were not helping.It was noted that the implant was for trigeminal pain.The patient consulted with their healthcare professional the month prior to the report and was told that the tissue on the dura had grown and the stimulation signals were not able to get through, so they had brain surgery in (b)(6) 2017 to address this.The patient stated that after the surgery they experienced two grand mal seizures.They didn't remember if they were attempting to turn stimulation on at that time or not.It was noted that the patient had surgical pain at the head incision site related to the recent 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 was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient had scar tissue around the epidural implant.The lead was placed in the subdural space during the revision.The hcp stated that they interrogated the implant for diagnostics relating to the seizures and it was found that the stimulation parameters were too high.The hcp adjusted the stimulation parameters and the loss of therapy, seizures, and surgical pain were resolved.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 6338250
• MDR Text Key: 67647870
• Report Number: 3004209178-2017-04054
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• Date Device Manufactured: 07/30/2015
• 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: 66 YR