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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 11/09/2015

Event Type  malfunction  

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the manufacturer representative saw the patient about a month ago and noticed that impedances were elevated around 1,000-2,000 ohms.The patient was seen for normal reprogramming a few times but on the day of the call ((b)(6) 2017) it was the first time that the manufacturer representative noticed the correlation between the high impedances and a lack of stimulation.Impedances were run at 0.7v and noticed the impedances at the bottom of the lead were about 1000 ohms but it started to increase going up the lead.At the top of the lead the impedances were around 3,000 to 4,000 ohms.Having the reference electrode at 0 led to higher impedances than when electrode 7 was the reference electrode.When reference was 0, impedances are low at the top and higher at the bottom but if switched to reference 14 it was the opposite.When the patient was programmed at the bottom of the lead the patient felt stimulation around 3-4v, when the patient was programmed in the middle of the lead they felt stimulation around 5-6v, and when programmed a the tip the amplitude could be turned all the way up and the patient would not feel anything.The patient still had pain and it had never been ¿the way it should be.¿ the patient needed low back coverage but felt stimulation in their legs up to their buttocks.There was a reported fall off of a ladder last year but there was no noticed a change with the stimulator after that fall.The patient had fallen again about a week ago.Electrode impedance testing was done at 3.0v and there were no anomalies found.The following results were recorded from different reference electrodes: reference 0 - around high 2000s to 4000 ohms, reference 7 - all below 2500 ohms, and reference 13 - high 2000s to 3000 ohms.It was noted that these issues had been since implant on (b)(6) 2015.No further complications were reported.

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 (rep) indicated that they did some additional programming for the patient to see if they could get some relief.The rep was going to give the patient a few weeks with the additional programming to determine if the issue was resolved.If the issue remains unresolved after a few weeks, a lead revision will be discussed.They noted that the leads may need to be repositioned anyways to get better coverage.The rep did not know the patient¿s weight.No further complications were reported.

Manufacturer Narrative

Corrected information: sex, date of birth.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: 6477024
• MDR Text Key: 72431668
• Report Number: 3004209178-2017-07936
• 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: 04/13/2017

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Date Device Manufactured: 12/16/2014
• 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: 68 YR