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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient was going to have an xray to look into why she was having pain in her back in a certain area when the device was running.The device was implanted for sciatic pain.The pain was in her upper back and center/left side of back; there was also a lot of pressure.This had been going on since 5 weeks after implant.The patient discussed this with her physician but was told everything just needed to heal.It worsened if she moved a certain way.A month and a half ago, the pain was ¿grabbing her so hard it almost brought her to her knees.¿ some days the patient couldn¿t move her arms up.As soon as her ¿feet hit the floor¿ she had pain.The patient also felt it when stimulation was off.The patient used to be able to turn stimulation off and it would go away, but that was no longer the case.She had also tried turning stimulation down as she thought that was causing the pain.The patient did not feel the stimulation running.The patient was told to switch to group c, which she felt in her toes, and left side of her leg and to her back.Twenty minutes later, she couldn¿t feel it anymore.If she moved a certain way, it would cut off.The patients left side had nerve damage that occurred before the stimulator surgery.The patient knew therapy was helping, however, because when it was in, her lower back did feel better.The patient had since shut the stimulator off.When she turned it back on 2.5 weeks ago, she didn¿t feel the stimulation running.She had a hard time programming it because she doesn¿t feel it.She then turned it off again and it had been off for over a week at the time of the report.Additional information regarding the outcome was requested, if received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.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.Product id: 97740, serial# (b)(4), product type: programmer, patient.(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: 4166970
• MDR Text Key: 4869508
• Report Number: 3004209178-2014-19547
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Date Device Manufactured: 02/27/2014
• 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 Age: 00044 YR