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

Model Number 97702

Device Problems Energy Output To Patient Tissue Incorrect (1209); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 10/01/2017

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 a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient was feeling shocking in their neck and up into the left side of their face occasionally, about every 10 minutes.The patient specifically noticed it if they were sitting down and they bend forward to the left.They said it feels like their regular stimulation but it's more of a shocking and feels like it's at a different frequency than their other stimulation.The patient turned the stimulation off but this didn't address the issue.The patient was reviewed on lowering voltages down to 0 volts but was told it shouldn't make a difference if the stimulation was already off.The patient had a bad fall from a ladder a year ago but this was unrelated to their system.The caller was redirected to follow up with their healthcare provider to have their system checked.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that patient was still getting shocked.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Event Description

Additional information received from the patient reported that they continue to having shocking even when stimulation is off.The patient was in the process of contacting the hcp to address the issue.No further complications were reported.

• 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: 7002987
• MDR Text Key: 92167640
• Report Number: 3004209178-2017-23186
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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,Followup
• Report Date: 01/30/2019

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: 08/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 02/16/2018; 01/22/2019
• Supplement Dates FDA Received: 03/01/2018; 01/30/2019
• Date Device Manufactured: 03/06/2015
• 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: 59 YR