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

Model Number 97714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Communication or Transmission Problem (2896); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Distress (2329)

Event Type  Injury  

Event Description

It was reported that the patient has had stimulation issues since implant.It was further reported that the stimulation was more in the left leg but it should be in the patient¿s right leg where their pain was.The patient reportedly felt stimulation in both legs but should have only been feeling it in the right leg.It was noted that the stimulation was shooting up their back into their leg.It was also noted that during the trial stimulation was in the right leg.The patient reportedly had meet with a manufacturer representative for programming but the stimulation was still not set right.The patient reportedly had to charge without being trained and noticed that their battery was getting low.The patient was reportedly charging with 6 bars but it was noted that the patient would lose the bars and have to readjust the antenna.It was further noted that the patient only charged to 50%.The patient reportedly was upset and felt like charging was overwhelming and did not realize they would have to do so much to do.It was further reported that the patient still had concerns but was working with their physician and/or company representative.It was further reported on 2014 (b)(6) that the patient did not have 50% or greater pain relief.The patient had some pain relief, but stimulation was stronger on opposite leg.The cause appeared to be due to lead placement being off and the patient was going to have a lead revision.Programming was not needed.The lead revision was being scheduled with a neurosurgeon.Additional information was requested, if received a follow up report will be sent.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3966643
• MDR Text Key: 4634390
• Report Number: 3004209178-2014-13671
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

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: 11/14/2014
• 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: 07/23/2014
• Initial Date FDA Received: 07/30/2014
• Date Device Manufactured: 12/19/2013
• 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: 00061 YR