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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913); Environmental Compatibility Problem (2929)

Patient Problems Muscular Rigidity (1968); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

Information was received from a patient implanted with a neurostimulator for non-malignant pain.It was reported that the patient's therapy was not working well and seemed to be no longer working, especially in the humidity, and she had a lot of pain.The patient was to follow-up with a healthcare professional and was redirected to her managing physician's office to schedule an appointment with a manufacturer representative (rep).The issue began in 2016, months prior to (b)(6) 2016.Additional information was received from the patient.It was reported that the patient's stimulator was not working at all for her.Additional information received from the patient reported that the patient notified her managing physician about the device not working well.The patient did not know what circumstances led to the device not working well; it was just not controlling her pain.It was noted that an appointment was made with a rep.

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 consumer regarding the patient.It was reported that there was return of symptoms and it didn't seem like it was working.The patient was in a lot of pain and has a lot of tightness.This was considered a gradual change in therapy which has started occurring in (b)(6) of 2017.The patient had not adjusted or changed programs and she didn't like to do that because she wants a manufacturer representative or health care provider to adjust it.The patient was redirected to her health care provider.No further complications were reported or anticipated.

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 patient.It was reported that the patient wanted to have a mri done because it didn't seem like they were getting relief from their stimulator.The patient had the device reprogrammed a few weeks before the event and was given 7 programs and none of them were working for them.The patient mentioned that their back was "killing them." the patient reported that the lack of relief occurred "a few weeks" before the date of the call, which was (b)(6) 2017.No further complications are anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported their device had lost it's effectiveness 6-8 months prior to the report (around (b)(6) 2017).The reason for their device was for the pain in their lumbar spine, which worsens when there is precipitation.It was also reported that in (b)(6) 2017 their device would not turn on and they could not charge it.They were scheduled to meet with a manufacturer representative (rep) on (b)(6) 2017 to have their device checked but the rep had not shown up to the appointment.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer¿s representative (rep).It was reported the battery was overdischarged on (b)(6) 2017.A rep spoke to the patient on (b)(6) 2017 because the patient was able to wake up their battery.The rep walked the patient through clearing a power on reset (por) with the patient programmer.No follow ups were scheduled with the patient, not healthcare professional (hcp) at this time.The ins was now working, it would turn on, it would charge, and the patient had therapeutic effect and pain relief.The rep mentioned they spoke with the patient in (b)(6) 2017 and were able to get good coverage.The rep then did not hear from the patient until they spoke with them on 2017-oct-10.No further complications were reported.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5930786
• MDR Text Key: 54024207
• Report Number: 3004209178-2016-18323
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2017
• Date Device Manufactured: 03/03/2015
• 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: 55 YR