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

Model Number 97714

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

Patient Problems Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 03/01/2018

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 representative (rep) and a consumer regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.It was reported that the patient had experienced a little shocking in both legs when walking every 20 steps.The patient stated that the therapy was intended for the lower back and not the legs.The rep reported that the doctor wanted to diagnose the shocking prior to the ins battery change.When conducting an impedance test today at 2.5 volts, the patient felt stimulation in the buttocks with all impedance values at 1000 ohms.They stated this was a sudden change in therapy.No further complications were reported.Follow up was conducted.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative (rep).The patient was turned back on at 1/12 voltage as they were scared to get shocked again.The impedances were run several times at lower and higher amps and were all normal.The rep stated that they are going to replace with a 97715 and possibly replace the lead if needed.The patient had no shocks, but couldn't sleep on their left side.The patient was asked to turn the left side down as they believe one of two targets were left.No further complications were reported or anticipated.

• 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: 7607225
• MDR Text Key: 111268794
• Report Number: 3004209178-2018-13583
• 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
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2018
• Date Device Manufactured: 11/28/2016
• 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 Age: 45 YR