MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO 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 05/29/2015

Event Type  malfunction  

Event Description

It was reported that stimulation was turning off.On (b)(6) 2015, the patient got up and there was no stimulation.She put her hands above her head and felt no stimulation.She then took a couple of steps and it turned on.She was in a recliner with her feet up and the implantable neurostimulator (ins) turned off and she got up and turned stimulation on.The patient was going to follow-up with her healthcare provider (hcp).It was noted that stimulation was off at the time of this call.Earlier in the week, she went to recharge her ins and had to turn the ins on because it was off.She was in the upright position at the time.It had happened twice the week of this call and the patient didn't know what position she may have been in when it happened.Follow-up was performed to determine if any troubleshooting had occurred, if a cause had been determined, if any intervention occurred, if the issue was resolved, and if the patient had any further concerns.This event will be updated if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id: 3888-33, lot# v136689, implanted: (b)(6) 2008, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 3888-33, lot# v378301, implanted:(b)(6) 2010, product type: lead.Product id: 37082-20, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.(b)(4).

Event Description

Additional information received reported that the patient had an appointment with her doctor on (b)(6) 2015 and her concerns were resolved.

• 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: 4853503
• MDR Text Key: 5806274
• Report Number: 3004209178-2015-11824
• 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: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Date Device Manufactured: 01/21/2015
• 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: 00045 YR