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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that the patient was not adequately trained on using the device and wanted to meet at the healthcare provider¿s office to train on charging.The patient reported she thought she charged once a couple days ago but stimulation stopped about two days prior to the event.It was reviewed with the patient how to line up recharger head over the implantable neurostimulator (ins) but the patient had zero coupling bars and the ins battery level was 0-25%.The antenna locate feature was used and started at 50 and ended at 54 with zero coupling bars.Troubleshooting was tried several times resulting in either poor communication or zero coupling.The patient also reported she was unable to adjust stimulation.The manufacturer¿s representative (rep) was going to call the patient to schedule a meeting.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 97740, serial# (b)(4), product type: programmer, patient; product id 97754, serial# (b)(4), product type: recharger; product id 3708260, serial# (b)(4), implanted: (b)(6) 2008, product type: extension; product id 3777-60, serial# (b)(4), implanted: (b)(6) 2008, product type: lead; product id 399930, lot# v049183, implanted: (b)(6) 2008, product type: lead.(b)(4).

Event Description

The company representative confirmed that they did not have to do trouble shooting with the patient so it was unknown if the recharge history matched what the patient was doing.The patient was trained in the office and was able to get coupling bars.The device was in continuous mode.It was thought the issue was due to lack of knowledge with how to use the equipment, this was not a product issue.The company representative gave the patient her card/phone number and was told to call if she had any more issues.The company representative has not heard from the patient again so it was thought the issue has been resolved.

• 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: 4152926
• MDR Text Key: 4930937
• Report Number: 3004209178-2014-18526
• 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,Followup
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2014
• Date Device Manufactured: 06/23/2014
• 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: 00053 YR