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 Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that the patient experienced stimulation in the wrong location from their implantable neurostimulator (ins).Specifically, the patient stated that no matter how they reprogrammed the device they were not able to target the pain on their left side (¿doesn't work at all on the left side at all¿).It was noted that the stimulation from the ins was not doing what the trial did and was not helping or covering their pain at all.The patient was told at a recent reprogramming visit that they may need to have a paddle lead implanted but they did not want to go through that again.The patient stated that the doctor who implanted ¿it¿ did not put it in right because the stimulation only targeted one part of their body.The patient was told they could have the device taken out by a family member and desired to do so.Additional information reported that the patient was still having concerns with their device or therapy but they were working with their doctor or a manufacturer representative.The patient was waiting for a date to remove their device.The stimulator was not working as anticipated.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: 2014-(b)(6), product type: lead.(b)(4).

Manufacturer Narrative

Concomitant: product id 977a260, serial# (b)(4), implanted: 2014-(b)(6), product type lead.Product id neu_ unknown_lead.Product type lead.(b)(4).

Event Description

Additional information received reported that during the implant they had been unable to get the second lead in.The patient had their entire system removed on 2015-(b)(6).

• 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: 4789201
• MDR Text Key: 5877056
• Report Number: 3004209178-2015-09559
• 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,Followup
• Report Date: 05/04/2015

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: 07/28/2015
• 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: 05/29/2015
• Initial Date FDA Received: 05/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2015
• Date Device Manufactured: 09/08/2014
• 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: 00078 YR