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

Model Number 97712

Device Problems Electromagnetic Interference (1194); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Complaint, Ill-Defined (2331)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: product id: 97740, serial# (b)(4), product type: programmer.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator for the treatment of failed back surgery syndrome and spinal pain.It was reported that the patient had an mri for an unrelated bad shoulder, and after the mri they started to feel the stimulation was too strong in their legs and felt like they were going to be "vibrated out of their skin".They tried to access their settings but started seeing poor communication where the patient programmer (pp) would not interrogate.They were able to get to the therapy screen and saw the therapy was on at 0.0v, but per the patient it was still stimulating them when it was off.They confirmed the antenna was secured while syncing with the implant, but the issue didn't resolve.After multiple attempts they were able to get the settings pulled up and reviewed that the patient was at 0.0v on p1 but that on p2 the patient was at 4.0.The stimulation was lowered to where they "normally" had it at 2.40, the patient was satisfied with the setting, and the strong stimulation was resolved.After placing the pp directly over the implant the poor communication was also resolved, though it was mentioned that the patient's bad shoulder made it difficult to hold the programmer over the implant.No symptoms were reported for the patient and 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: 7660347
• MDR Text Key: 113393833
• Report Number: 3004209178-2018-14971
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2018
• Date Device Manufactured: 06/06/2016
• 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: 64 YR