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); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a family member/friend concerning patient with implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was having trouble ¿with the stim¿ because it was not connected right and does not seem to be working anymore.It was not helping, and the patient was experiencing extra pain.The patient met with the manufacturer representative to see if programming could be adjusted and ¿it feels like maybe only one lead is possibly connected to where it should be.¿ they were going to try and set up an appointment in a month to check if the lead is in fact disconnected and then take steps to fix it.The representative instructed the patient to recharge the ins and then turn therapy off until his next appointment.This started about 3 months ago.No further complications were reported/anticipated.Omitted information related to (b)(4) ¿ antenna not staying in place.

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 patient via manufacturer representative (rep).It was reported that the patient¿s implantable neurostimulator (ins) was not giving him pain relief despite having a lead revision in september, he had never had good pain relief.The contributing factors were unknown, but it was noted that the patient did not get pain relief from the ins as he did during the trial.Impedance measurement were within range, lead 0-7 provided coverage on the left side up to the hip area, and lead 8-15 gave some abdominal stim, so he did not use this lead.The rep reprogrammed and gave the patient 3 new groups that all gave him left hip coverage.The patient was advised to try all three groups prior to the next appointment in one month after the report.Group also had 1 program that gave some right sided coverage, but also some belly stim.The issue was not resolved at the time of the report and per the physician, if the patient continued to not get pain relief, he would consider a pump trial.There were no further complications reported or 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: 7639540
• MDR Text Key: 112437850
• Report Number: 3004209178-2018-14406
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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
• Date Manufacturer Received: 04/23/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR