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); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding their neurostimulator (ins) that was implanted for failed back surgery and spinal pain.It was reported that the patient felt shocking sensation down the leg.And one time felt it was in the abdomen.It was reported that there was an issue with stimulator.Patient would turn off unit and it actually turned back on itself.Patient checked with remote and it had been turned back on itself.Patient stated that they 2-3 times turned actual machine off and shouldn't be on.Couple of hours later, all of a sudden it turns back on and feels a certain way and turns back on.Patient stated that it did not do this every time they turned off the stimulation.The sensation was down the leg.It was reported that the issue started about 4 weeks prior to the date of the report.An exact date was not provided.Patient was redirected to their hcp.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer reported that they did not know the cause of the shocking or the device turning itself on.The patient stated that no actions were being taken at that time and they had been told to monitor the problem.

• 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: 7064260
• MDR Text Key: 93241609
• Report Number: 3004209178-2017-24465
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

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: 07/14/2018
• 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: 11/27/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 12/27/2017
• Date Device Manufactured: 08/17/2017
• 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: 44 YR
• Patient Weight: 99