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

Model Number 97714

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Date 11/01/2017

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 regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that within the last month (b)(6) 2017 the device that controller their shoulder kept hammering them all of the time.It was confirmed the stimulator was implanted for their shoulder.During the call the settings were turned down to 0.0 and it was turned off, but the patient still felt the sensation.No further complications were 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 reporting that the steps taken to resolve the issue of the "hammering" sensation being felt in your shoulder even when the implant was turned down to 0.0v and turned off was the patient called the manufacturer, their doctor and then talked to someone who "walked" them through the steps to turn both 1 and 2 off and the problem was solved.It was reported the patient weighed (b)(6) at the time of the event.No further complications were reported/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: 7185270
• MDR Text Key: 97067132
• Report Number: 3004209178-2018-00693
• 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: 02/09/2018

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: 05/28/2018
• 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: 01/09/2018
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/09/2018
• Date Device Manufactured: 07/06/2017
• 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: 78 YR
• Patient Weight: 134