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

Model Number 97712

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 12/12/2017

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 patent regarding their neurostimulator (ins) that was implanted for spinal pain.It was reported that patient feels stimulation all the time even when off/on.Patient was not sure if it working or not.Patient still has sensation when on/off.Patient was in the hospital some time ago and had an mri and knew stim was off.On (b)(6) 2018 patient had pain in back, hips, ankles and feet and been having pain there for some time.That was also the day it was the worst yet.Patient has had pain around implant site since implant.Patient mentioned other surgeries which were before implant and not related.Patient stated that the pain started a while ago, a year or two; an exact date was not provided.A manufacturer rep later stated that they contacted the patient and will be seeing them.No further complications were reported/anticipated.

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).The rep reported that the cause of the patient feeling stimulation sensation all the time when on/off was determined to be user error.The patient had confusion regarding stimulation and working the programmer correctly to turn her stimulator (ins) on/off.The rep reported that the pain in her back, hips, ankles and feet were all pre-existing prior to the ins implant.The rep reported that the patient was reprogrammed in the office on (b)(6) 2018 to adjust her ins settings in order to achieve optimal settings to help reduce her painful areas.The issues were resolved.No further complications were reported.

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: 7655409
• MDR Text Key: 113389476
• Report Number: 3004209178-2018-14784
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/12/2017
• 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