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

Model Number 97713

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Cut In Material (2454)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 03/16/2015

Event Type  Injury  

Event Description

It was reported that the patient had stimulation in the wrong location.The patient had an adjustment a week prior, but the stimulation was not in the right location.The patient felt it in the knee area.The patient stated that it felt like his knee was going to ¿blow off.¿ later it was reported that the patient met with the manufacturing representative for some minor adjustments to their programming.The patient stated that the feeling of stimulation was just a little too much in his knee.The manufacturing representative was able to relieve by adjusting the anodes and cathodes.The patient left happy.About 2 months later, it was determined that the suture cut through the bumpy anchor and the lead migrated out of the epidural space.The patient experienced less than 50% therapy relief at the lead location.X-rays and reprogramming were performed.The lead was explanted.The patient was doing well with a new lead and the proper placement.

Manufacturer Narrative

Concomitant products: product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 97740, serial # (b)(4), product type programmer, patient; product id 97754, serial # (b)(4), product type recharger; product id neu_unknown, product type unknown; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead.(b)(4).

Manufacturer Narrative

Analysis of the lead (s/n (b)(4) found no significant anomaly (b)(4).The lead body¿s outer insulation was melted.Analysis of the stim.Anchor (s/n and l/n unknown) found the injex was torn (b)(4).

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.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: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.Product id 97791, product type: accessory.Analysis results were not available at the time of this report.A follow up report will be sent when analysis is completed.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the device diagnosis was lead migration/dislodgement.The clinical diagnosis was inadequate pain control from baseline.The patient reported inadequate pain control in his left foot.The outcome was resolved without sequelae.Interventions included explanting and replacing the lead.Diagnostic methods included device interrogation.Reprogramming was unsuccessful.Fluoroscopy revealed significant lower lead migration.The etiology was noted as related to the device or therapy and unlikely related to the implant procedure.The etiology was noted as related to the lead.There was no known cause.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 4805463
• MDR Text Key: 5931108
• Report Number: 3004209178-2015-09936
• Device Sequence Number: 1
• Product Code: LGW
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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: 00047 YR