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

Model Number 97714

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Sleep Dysfunction (2517)

Event Date 06/10/2018

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 consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient is trying to get a hold of their local rep because they need the scs adjusted.The patient stated that they fell on (b)(6) on their right side where the ins is, and since they have had pain all over, but especially in the middle of their back from the breast bone - down.The patient stated that the device is implanted near their should blades.The patient stated that the pain is "about killing" her, nothing that they have muscle spasms and pain wakes them up at night.The patient is taking muscle relaxers and pain pills, but they are not helping.The patient has tried adjusting stimulation level, but it also did not help.The patient's healthcare provider (hcp) ordered x-rays to be taken, but the hcp stated that nothing is "broken" with their system.The patient is tired of hurting and was requesting assistance.The patient will follow-up with their hcp and manufacturer's representative (rep) regarding the post fall pain and spasms.No further complications were reported or anticipated.No device allegations were made.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient.It was reported that the patient adjusted settings on the ins but the pain and spasms would not go away.The patient had therapy scheduled for (b)(6).No further complications were reported/anticipated.

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: 7658903
• MDR Text Key: 113397273
• Report Number: 3004209178-2018-14897
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/11/2017
• 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
• Patient Weight: 91