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

Model Number 97714

Device Problems Intermittent Continuity (1121); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Swelling (2091); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

A coupling problem occurred today.There were bandages present over the pocket site.Swelling was also present.The antenna locate feature was performed, started at 78 and got up to 82, but was unable to hold the antenna in the same location to start charge session at 82 location.Highest coupling achieved was two bars.The patient continued to charge with 0-2 bars fluctuating.While performing the antenna locate, the patient¿s arms got tired as she took the belt off to move the antenna.The antenna was not long enough to go around the patient¿s belly.The patient was not trained adequately on using the device, she was not aware that she had to recharge.The patient¿s health care provider (hcp) told her she should not sit for more than 30 minutes because if she sits for long periods of time, stimulation starts vibrating fast on leg.This has been since implant.The patient could remove the bandage on (b)(6) 2014.A week and a half later it was reported that the patient has an issue with her unit, her device was not charging.The patient was not able to adjust stimulation.An information request was made regarding the recharger/recharging.A coupling problem was again reported, the patient was only able to get four bars.The patient issue was resolved through going through the instructions.Eight days later, the patient reported that the most boxes she was able to get shaded were two.The patient had issues getting good coupling.The company representative has tried working with the patient, tried different positions, and using the belt.Another recharger was not tried to see if that solved the issue.A new antenna was ordered for the patient to see if that solves the issue.The antenna was damaged.If that does not work, they may have to go in to reposition the implantable neurostimulator (ins).The patient could feel the ins and she has an appointment on (b)(6) 2014 with her hcp.The antenna was not returned.C500.Additional information has b een requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up will be sent.

Event Description

Additional information received reported that the patient was having trouble with the skin on their back overlapping and ¿it wouldn¿t keep showing bar.¿ the patient was trying new ways.The patient had an appointment on (b)(6) 2014 and was instructed to order a new part.The patient still had concerns regarding their device or therapy but was working with their doctor or manufacturer¿s representative (rep).

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 37791, serial# unknown, product type: recharger.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

• 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: 4217220
• MDR Text Key: 4968628
• Report Number: 3004209178-2014-20745
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• 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
• Date Manufacturer Received: 11/06/2014
• Date Device Manufactured: 08/28/2014
• 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 Age: 00069 YR