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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Unintended Collision (1429); No Device Output (1435); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Weakness (2145); Numbness (2415); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that she had fallen and messed up her stimulator.The patient stated that her healthcare provider had told her not to turn the stimulator back on because when it was on it would send lightning bolts to her body.The patient reported that she wanted to take the stimulator out and she couldn¿t deal with the pain she was in because it was really bad.The patient noted that both her hips hurt and she couldn¿t walk longer than five minutes because her left leg would go out.The patient had an appointment with her healthcare provider in (b)(6) and she was looking into getting a drug pump.Further information received from the consumer via the manufacturer representative reported that they had begun to experience strong electrical shocking sensations in (b)(6) 2016 and turned off the implant.The patient had turned it on briefly in may and experienced shocking and turned the device off and it remained off.The implant was currently in overdischarge.The patient reported that she falls sometimes due to weakness/numbness and her pain and noted no injuries or changes in stimulation as a result.A trickle charge and power on reset were done for the overdischarged implant.The issue was not resolved at the time of the report.The indications for use were failed back surgery syndrome and spinal pain.Additional information was received from a manufacturer's representative regarding an implantable neurostimulator for the treatment of failed back surgery and spinal pain.It was reported that the meeting with the rep had been cut short, and the device was not pulled out of overdischarge.The patient is to meet with a different representative.The only way the patient could reportedly deal with the shocking sensation was to turn off stimulation.The representative is scheduled to meet with the patient on (b)(6).

Manufacturer Narrative

Event Description

Additional information was received from a manufacturer's representative regarding an implantable neurostimulator for the treatment of failed back surgery and spinal pain.It was reported that the patient was successfully pulled out of overdischarge.The representative also reported that the patient stopped using their stimulation in may as they were feeling overstimulation, shocking and jolting sensations at the pocket site and to the spine area, and intermittent at the knee.It was reported that after the patient was pulled from overdischarge impedances were checked, and all were within normal limits (800-900 ohms).The patient reported feeling shocking/jolting between 2.6 and 2.7 volts.The patient reported that they had fallen around 5 times and wasn't sure if it affected the system.An x-ray was recommended.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative.The representative reported that the patient was going to have a consult for revision.

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: 6076531
• MDR Text Key: 59125557
• Report Number: 3004209178-2016-23159
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 01/09/2017
• Supplement Dates FDA Received: 11/10/2016; 11/15/2016; 01/10/2017; 09/26/2017
• Date Device Manufactured: 12/08/2015
• 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: 27 YR