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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Electric Shock (2554)

Event Date 02/13/2017

Event Type  Injury  

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 manufacturer representative (rep) reported that impedance measurements were taken which showed normal results.It was reported t hat the implant was not on and there were no trauma/falls reported that could be related to the issue.The patient told the rep that they were lying in bed when the shocking started.The patient had cervical, surgical lead and shocking was being felt in their arm.Per the rep, the patient had not had an overdischarge or power on reset (por) event of any kind recently.There was a report that the patient experiences the symptoms when the implantable neurostimulator (ins) is off.The patient was visited by the rep in er.When they checked the system with the clinician programmer, stimulation was already off.They turned the patient's voltages down to 0 volts.It was reported that they were going to consult a neurosurgeon for the situation.The shocking was reported to be a sudden change in therapy/symptoms.The consumer reported a change in therapy described as intermittent/erratic.It was reported that the patient was experiencing a jolting sensation similar to an electricity feeling behind their neck where the leads were located.After feeling the jolting, the patient lost all feeling in their back and neck (shoulder blades down to their butt).They had slowly regained the feelings in their neck but still had not been able to feel anything in their back.Since the jolt, they had passed out from the p ain several times now from the jolt being too intense.The patient reported to be just laying in bed and had not done anything differently from normal when they first started experiencing the jolt.They reported the sensation was intermittent but was close to a constant sensation.They noticed that if they tilt their head forward, they would feel more of the jolt.No medical test or emi environmental exposure was reported and the patient used their programmer to turn their stimulation off since they first started experiencing the jolt.The cause of the shocking/jolting sensation was not determined.It was reported that the patient's impedances were checked and all were within range.Also, while the patient was turned off, their programs were still turned up so as an extra precaution, the patient's programs were also turned down to zero.Other steps taken by the physician were unknown.The patient was also offered a reprogram if they would like to do so but had not been in touch to arrange that.Relevant medical history includes spinal pain.No further patient complications have been reported as a result of this event.

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 the patient on (b)(6) 2017.The patient reported that the issue was not resolved, but was done with the device and wanted it explanted.The patient reported that the healthcare provider (hcp) placed it in wrong and the patient had not gotten any relief.The patient reported that for 6 weeks or so, the patient lost feeling from the waist down and in the legs as soon as the hcp implanted the device.The patient reported that they could not even go to the bathroom.The patient reported that they had tried all the reprogramming but nothing was working.The patient reported that they were in contact with a hcp that could explant the device.No further complications anticipated.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6421322
• MDR Text Key: 70514686
• Report Number: 3004209178-2017-06039
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 04/24/2017

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: 12/28/2016
• 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: 02/20/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided; 04/04/2017
• Supplement Dates FDA Received: 04/24/2017; 10/02/2017
• Date Device Manufactured: 02/03/2016
• 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 Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 75