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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Unexpected Therapeutic Results (1631); Malposition of Device (2616)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that the patient had stimulation in the wrong location following implant.The patient needed stimulation to be in the thighs, back, buttocks, and lower back, but stimulation kept going to the feet and calves.If stimulation was turned up to 1.70 it was so strong it hurt.If it was turned down to 1.45, 1.50, 1.60 it didn¿t help with the pain.The patient reported their feet were flying because of the stimulation.It was reported the temporary was perfect and awesome so they went ahead with the permanent; but this was nothing like the temporary.The patient had three or four adjustments and was wondering how many times it would take to get the device adjusted before it worked.The patient received assistance from their doctor and company representative on (b)(6) 2014 and their concerns were resolved.The patient¿s health care provider (hcp) reported that the patient did not have a 50% or greater symptoms reduction.It was not device related.Reprogramming was attempted for extended appointments, times three, without significant improvement.An x-ray on (b)(6) 2014 did not indicate significant movement of the lead.The patient experienced a gradual loss of therapeutic effect.The patient did not experience a loss of stimulation.The patient was scheduled for a lead revision on (b)(6) 2014.It was confirmed that the patient had a very successful trial.They were using stimulation from the proximal portion of the lead.So when they did the implant the doctor positioned the lead to approximate where the electrodes were during the trial.The patient did not receive effective stimulation from this lead placement, so the doctor did a revision to move the lead up.Now the patient has effective therapy and has recovered without problem.If additional information is received, a follow up report 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).

• 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: 4318185
• MDR Text Key: 16089143
• Report Number: 3004209178-2014-23662
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Date Device Manufactured: 09/04/2014
• 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