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

Model Number 97714

Device Problems Break (1069); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Injury (2348)

Event Date 08/25/2014

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.

Event Description

Information was received from a patient.It was reported that their therapy had been totally ineffective.The patient stated that if they couldn't have a dti mri then they wanted to have the device removed.It was reviewed that explants would be a medical decision.The patient noted that the mri was not due to a problem with the device or therapy.Indication for use is spinal pain.Information was received from a patient with an implantable neurostimulator (ins) for spinal pain and complex regional pain syndrome.It was reported that the patient¿s therapy has never really been effective since implant ((b)(6) 2014), but they kept stimulation on for a little stimulation help.It was also reported that the patient turned the device off a couple of days ago ((b)(6) 2017), because they were having pain.When they turned it back on they tried different programs, but didn't feel stimulation with any of the programs.Additional information received from the consumer indicated that they were at a clinic waiting to have an mri.The patient currently had an mri in their arm that was painful.The patient was seeing 0¿s in mri mode.The patient noted that they had mris in the past and did not recall seeing the full body icon.The patient requested a manufacturer representative (rep) to program the eligibility.The patient had crps all over their body and half a foot nerve injury in the leg.The patient was unable to determine the mri eligibility.The patient was able to have mris with no problems for the last 2 years.The patient noted that the error was on the manufacturer and the manufacturer needed to fix the problem.It was noted that the patient was apparently having unsafe mris due to a programming error.The patient would ask the clinic to page a rep.Additional information received from the patient reported that their stimulation failed about two weeks prior to the date of this report.It was reported that the cause of the loss of stimulation, ineffective therapy, and pain was due to the lead failing.The patient also mentioned that their system was never programmed for mri mode upon implant, and that they were unable to get it into mri mode using their programmer.

Manufacturer Narrative

(b)(4) applies to both leads (977a260).

Event Description

Additional information received from the patient report that they had a broken lead, and that only 6 of the 8 contacts were working.The patient noted that they have known about this since (b)(6) and that they have met with the rep multiple times in the last couple months.The patient stated that they had a recent mri and that the lead seemed to be in place.The patient went on the re-iterate issues already reported.

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: 6294705
• MDR Text Key: 66321478
• Report Number: 3004209178-2017-02339
• Device Sequence Number: 1
• Product Code: LGW
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Date Device Manufactured: 05/01/2014
• 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 Age: 47 YR