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

Model Number 97714

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

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 10/02/2014

Event Type  Injury  

Event Description

It was reported that the patient¿s therapy isn't as good as it was during the trial.She was getting coverage in the legs, but not in the back and buttocks where most of her pain is.There was less than 50% therapy relief.It was reported that the patient¿s therapy isn't as good as it was during the trial.She had great coverage and pain relief during the trial, but not after implant.She was getting coverage in the legs, but not in the back and buttocks where most of her pain is.There was less than 50% therapy relief.She was given some additional programs at her post-operative appointment and instructed by her physician to give it time for normal swelling to go down.On (b)(6) 2014 the patient was in a lot of back pain.None of the programs seemed to be getting to her back or buttocks.Follow up information indicated that an x-ray was taken and it verified that the leads had not migrated.The only cause determined by the physician was that the implant leads were not placed identical to the trial leads.The device functioned properly, so the lead placement was noted as the cause for lack of therapy.Impedances were all normal.The leads were changed out as well as being placed closer together.However, the patient required a second revision surgery on (b)(6) 2014.The leads were repositioned and the patient was woken up to test placement.Regardless of where the leads were adjusted or what electrode configurations were used, the patient had uncomfortable rib and stomach stimulation with no stimulation in the back or leg.After much testing, it was decided it was best to remove the device.

Manufacturer Narrative

Concomitant products: product id: 977a260: serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260: serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a160; serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a160; serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260: serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260: serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 97740: serial# (b)(4), product type: programmer, patient.Product id: 97754: serial# (b)(4), product type: recharger.The implant date was noted as (b)(6) 2013.However, the manufacturing information conflicted with this.The manufacturing date was noted as after the implant date.Additional clarification was requested.(b)(4).

Manufacturer Narrative

It was clarified the implant date was a year off in error.Field updated.(b)(4).

Event Description

It was further reported that the patient was still sore but was doing well.

• 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: 4247982
• MDR Text Key: 5107686
• Report Number: 3004209178-2014-21520
• 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,Followup
• Report Date: 10/22/2014

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: 04/14/2015
• 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: 11/14/2014
• Initial Date FDA Received: 11/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• Date Device Manufactured: 05/23/2014
• 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: 00039 YR