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

Model Number 97714

Device Problems High impedance (1291); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2017

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 37714, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.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

A consumer implanted for radicular pain syndrome (radiculopathies) and spinal pain reported they turned the implantable neurostimulator (ins) up higher on (b)(6) 2017.After turning the implant up they saw the out of regulation message on the patient programmer (pp), but this was only present on one ins, not the other, even when the same pp was used.The consumer didn't know how to clear the message so the high setting stayed on while the consumer was in other positions like sitting or being in the car.Eventually the consumer cleared the code and turned the ins off.No further complications were reported/anticipated.Additional information was received from the patient.It was reported that patient had his implantable neurostimulator (ins) off for 5 days and when he turned his ins back on this past week ((b)(6) 2017) that he saw the out of regulation (oor) code 3 times.The patient stated that his settings were currently were lower than typical.It was reviewed how to bypass the oor to turn the stimulation off and then turn the stimulation on.No patient symptoms were reported.The patient was redirected to their healthcare provider to have the ins interrogated.It is unclear which ins was displaying the oor message, as the patient is implanted with two different devices.The indication for implant was non-malignant pain, cervical radiculopathy, radicular pain syndrome, and spinal pain.

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 manufacturer representative stating that they met with the patient and checked impedances on the device.They found electrode 15 had a high impedance.The rep programmed without using electrode 15, moving the patient's electrode configuration up one level.Patient was reported to be having good stimulation without electrode 15 active.

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 form the manufacturer representative reported that they saw the patient because the patient was still seeing the out of regulation code.Impedances were checked and electrodes 11 and 15 were greater than 10000.It was noted that the patient had groups a-e but only used group e.The representative deleted all groups other than e and group e did not use electrodes 11 or 15 in programming.It was mentioned that the patient encountered the upper limit screen at one point when his voltage was only at 2.2 and he could not increase to 2.3, but it only happened one time.It was stated that the patient tried to turn the stimulation off one time and it would not turn off and the device turned itself off a few hours later.Further information received from the consumer reported that he had the programming redone that resulted in the out of regulation message and the last reprogramming seems to have fixed it.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6477074
• MDR Text Key: 72556826
• Report Number: 3004209178-2017-07941
• 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,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Date Device Manufactured: 02/22/2016
• 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: 42 YR