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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); No Device Output (1435); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for non-malignant pain.The patient stated that since implant they have had pain from the device not working for them.Shortly after implant they noticed that their ins would not turn on.They notified their manufacture representative (rep) about 2 weeks after implant.It took about a month and a half for the rep to meet with the patient.When the rep met with the patient likely at the end of (b)(6).The issue was resolved and for 4 days their therapy worked for the patient.This was the only time that the therapy helped the patient¿s pain.After the 4 good days the patient reported that the therapy started working intermittently/was not working.They were not feeling stimulation.They could see it charging but it would not turn on.When they would feel stimulation it was in thewrong location.They notified their rep about it probably late (b)(6).They set up appointments to meet the rep but the patient was never able to meet with the rep to resolve the issue.The patient reported that their stimulation should be in their back but instead it is in their chest, heart, and under their shoulder.It is uncomfortable especially since they have pre-existing heart issues.Initially when the patient felt the stimulation in the wrong location they thought their pre-existing sciatica returned but then they realized it was just the stimulation sensation.The patient reported that within the last month which they then stated has occurred for about 3 months their stimulation will turn on by itself.It is unexpected and scares them.The stimulation is in their wrong location still and it uncomfortable.They notified their rep of the stimulation turning on by itself 3 months ago.The patient declined troubleshooting during the call on (b)(6) 2017 and instead wants to be reprogrammed with someone in person.The patient noted that at this point they may want the ins removed.Patient services recommended seeing a doctor to manage their device but the patient stated that they do not need one.An email was sent to local reps to schedule a programming session.The rep replied on (b)(6) 2017 indicating that they would contact the patient right away.Additional information was received from a rep on 2017-oct-25.The rep saw the patient on (b)(6) 2017 and cleared the power on reset (por).They then reprogrammed the stimulation.They narrowed the pulse width and the stimulation came out of their ribs.This was the first time they had met the patient.They believe a different rep helped them with the recharging prior to their visit.Additional information was received from the other rep on (b)(6) 2017.(b)(6) 2017 was the first time that the rep met with the patient and the device was in an overdischarge state.The rep was able to successfully charge the device back up.It was noted that the patient had compliance issues with charging their device.On (b)(6) 2017 the patient notified the rep that they were in pain and would like to get an adjustment.The rep noted there were times in the past that they were not able to keep their appointments with the patient which resulted in the patient getting upset.On (b)(6) 2017 they met with the patient and found that their device was overdischarged again.They were able to get the device charged up and a por was cleared.The patient also alleged that they experienced shocking from the device after the overdischarge was recovered.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacture representative (rep) on 2017-oct-31.The rep stated that they previously met with the patient because the patient stated that something was wrong with the device with the battery turning on and off but the patient told the rep it was charged when it really was not.The device was dead for quite some time per the caller.The rep waited 30 minutes for the reset and it did come back up within that 30-minute time frame, so the rep sent the patient home telling them to make sure they fully recharged the system.The rep stated that they thought everything was taken care of and as far as they know everything is fine now as the other rep saw the patient and addressed their concerns/issues.No further complications were reported/are anticipated.

• 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: 6984818
• MDR Text Key: 91118944
• Report Number: 3004209178-2017-22689
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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: 11/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 11/03/2017
• Date Device Manufactured: 12/21/2015
• 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 Age: 53 YR