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

Model Number 97714

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/08/2014

Event Type  Injury  

Event Description

The stimulation was not helping and the patient¿s health care provider (hcp) wants an mri of the patient¿s back to check if there was something else going on as to why the stimulation was not helping with pain relief.Mri compatibilities were reviewed.The area to be scanned was the knee, i-spine.The patient has never had therapeutic effect.The patient had a successful trial, in fact he was able to cut his oral medications down by half, however, since receiving the permanent implant has not got any pain relief.The patient also has pain in areas he did not have before and could hardly bend.Stimulation targets were for back, glutes/hips, and thighs.Hcp told the patient the leads were placed in same area as where the trial lead was placed.The patient felt stimulation and numbness, however, no pain relief.The patient was back to taking his oral medications as that helps better than the stimulation.The patient has been working with a company representative and hcp regarding this issue since shortly after implant.An information request was made regarding the patient programmer (pp).It was confirmed that the patient was able to set his device to mri mode and the pp showed full body.It was later reported that the patient did not currently have a 50% or greater symptom reduction.The cause was not determined.Reprogramming has not rectified the problem.A battery replacement will occur, but was still being scheduled.The patient was okay, but not receiving effective therapy.Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Never having therapeutic effect was still reported five months later.The therapy has been a disappointment since it铠been put in.The trial was outstanding, and the pain went away entirely in all areas.The patient has had no success with the permanent implant.The patient was even having pain in places he did not have pain before.The pain was across his back and where the implantable neurostimulator (ins) was located which he did not have before.The area around the ins was sore.There was pain down both legs and hips, in the calves and feet, which he did not have before.The device was implanted to help with soreness in the patient's back and going down his left right side of hips.The patient would get cold and numbness and his gluts would become painful going into his thighs.They were trying to do an mri to have things looked and the patient was having trouble finding someone to do this with his device.A few weeks ago the patient had an mri for his knee.They were now saying they have been told by the device manufacturer that the patient should not be in the mri field for more than 30 minutes.Device manufacturers have been meeting with the patient and were aware of this issue all along since implant, they have been trying to move settings and make adjustments but nothing was helping.Six days later mri compatibility guidelines were requested for the i spine and t spine.

Event Description

Additional information received reported that the patient still had concerns with their device or therapy and their concerns were not resolved.It was not relieving pain like the trial period.The patient was still having problems.

Manufacturer Narrative

Other applicable components are: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

The consumer reported that the trial worked great but after the permanent implant, the coverage was not that great.It was reported that they were having tremendous amount of pain when they walk.Some days, they could walk for miles but most days, they can only tolerate 20-30 feet before their gluteus and hip pain started to intensify.The patient does exercise 3 times a week.There was a report of a gradual change in therapy and/or symptoms.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4265543
• MDR Text Key: 5033734
• Report Number: 3004209178-2014-21952
• Device Sequence Number: 1
• Product Code: GZB
• 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,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2016

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: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 11/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2014; 01/08/2015; 08/09/2016
• Date Device Manufactured: 06/03/2014
• 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: 00071 YR