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

Model Number 97702

Device Problems High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported that the patient had a loss of stimulation and therapeutic effect.The patient still felt stimulation but it was no longer effective to alleviate his pain.It was also noted that stimulation was in the wrong location.Upon interrogation, all electrodes had impedances of greater than 10,000 ohms.The patient had a limb fall on him that landed near the generator site a few months ago.It was unknown if this had anything to do with the impedance issues.X-rays were ordered to check lead placement.The x-rays were done on a walk in basis and it was unknown when these were done.The patient had a follow up appointment scheduled for (b)(6) 2015 to discuss the x-ray results.A possible revision was discussed but not planned.It was also clarified that the impedance issue was only on the 0 electrode when paired with all other electrodes.Impedances were not high when any of the electrodes were paired with any electrode other than 0.The 0 electrode was not used in any of the programming.Additional information regarding further troubleshooting, results of the xray and outcome were requested.If received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical 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.(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: 4600412
• MDR Text Key: 5631869
• Report Number: 3004209178-2015-04721
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2015
• Date Device Manufactured: 06/25/2013
• 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 Age: 00073 YR