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); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 39565-65 lot# serial# (b)(4) implanted: (b)(6)2010 explanted: product type lead.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

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.Information was reported the patient's second implant that never worked from the first day and it was so hard to get to a program that relieved her pain.The patient said she is a patient that uses the therapy almost all the time.Patient reported that she met with a manufacturing representative (rep) like 10 times in two years for reprogramming, but patient stopped meeting with rep because nothing worked and they could never get back to the same stimulation she felt with her first device.Patient stated the kind of tingling sensation she felt with the 2nd device was more like "waves" and had more "waves" than tingling, patient said rep was never able to get to the type of stimulation that felt like rapid, small tingling sensation that took away the pain.Patient said after the 2nd implant was put in she started to feel "a bad tingling sensation" in the area where the electrodes go in the upper back.Patient stated tingling sensation was around the lead where the go inside exactly where "the upper wound is" (area on back where patient has scar where lead was inserted) and felt it when she went to turn off the implant, patient said tingling only started up when device was off.Patient said the tingling was so bad that she has to rub her back to relieve the sensation in an area where she didn't have any problems (patient had stated she got the device for her lower back).Patient said tingling wasn't every day and was only when it was off and tingling hasn't happened yet.Patient had x-rays taken and the lead wasn't out of place and that was one of the reasons they kept the lead.Patient said a ct scan to see if her cervical vertebra were giving her back problems but there was no problem in her cervical vertebra and they couldn't find the problem.Patient said since her 2nd device never worked it was replaced with a another companies device recently and she was still in recovery from surgery but the lead was left in and connected to the new battery.Patient said she was upset because the other rep told the doctor they were supposed to change the lead but changed his mind in the middle of the surgery and left lead in.Patient said she had wanted to the lead replaced so that she could get an mri to diagnose a preexisting problem she had prior to device.The patient was redirected to follow up with healthcare provider (hcp) to discuss why the leads were left in and it was reviewed that was a medical decision.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from consumer stating that the second device never worked as effectively as the first one for pain and a new tingling sensation was felt in areas where there was no stimulation programmed when stimulation was off.There was no change in activity level occurred and the new programming of the device was felt differently and was uncomfortable as the stimulation/waves/buzzing were different.No further complications were reported as a result of this event.

• 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: 6973737
• MDR Text Key: 90104813
• Report Number: 3004209178-2017-22421
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 11/29/2017
• Date Device Manufactured: 07/20/2015
• 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: 51 YR
• Patient Weight: 75