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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Labelling, Instructions for Use or Training Problem (1318); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/15/2016

Event Type  malfunction  

Event Description

A consumer reported the patient was implanted on (b)(6) 2016 and was supposed to feel stimulation in both their arms and neck, but as of (b)(6) 2016 they weren¿t feeling stimulation in their neck.The patient tried increasing stimulation, and could feel it increasing, but not in their neck.The manufacturer¿s representative (rep) was going to call the patient regarding the issue.Relevant medical history includes spinal pain.

Manufacturer Narrative

Concomitant medical products: product id neu_label_acc, product type: accessory.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 received from the patient indicated there was a loss of stimulation.The patient had been programmed by a manufacturer representative (rep) but since then the patient had done something with the programmer and ¿screwed it all up.¿ stimulation was only reaching the left side.Stimulation was strong in the left are up to the neck, but was weaker on the right side and stimulation was supposed to target both arms up to the neck.Therapy did help on the right side when the patient cocked their head to the right and could not feel stimulation when laying down.The patient also saw a poor communication screen when trying to communicate but was able to bypass it.Adjusting stimulation did not resolve the issue.Circumstances that led to the lack of stimulation in the neck included two fusions resulting in nerve damage and medication not working.The patient was having problems programming and understanding the manual for the stimulator.Steps to resolve the lack of stimulation included physical therapy, ¿tens¿ unit, medication and injections.

Event Description

Additional information provided by a manufacturer representative reported that the patient was doing fine.The manufacturer representative stated that they met with the patient in the clinic for reprogramming as well as re-education.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5922081
• MDR Text Key: 53728072
• Report Number: 3004209178-2016-18110
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Date Device Manufactured: 06/30/2016
• 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: 51 YR