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); Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 97714, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.

Event Description

A patient reported that they were getting poor communication on both of their implantable neurostimulators (inss).It was reported that the patient wasnable to communicate with their implantable neurostimulator recharger (insr) and last felt stimulation a week prior to the date of this report.It was noted that the patient's last successful charging session was a couple of weeks ago.The patient was to follow up with their healthcare provider (hcp) to get a physician mode reset (pmr) performed.It was noted that the issue started a day prior to the date of this report.Indication for use is spinal pain.

Manufacturer Narrative

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

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6083102
• MDR Text Key: 59357621
• Report Number: 3004209178-2016-23358
• 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: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2016
• Date Device Manufactured: 03/10/2015
• 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: 50 YR