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

Model Number 97702

Device Problems Overheating of Device (1437); Ambient Noise Problem (2877)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 06/25/2018

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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that this was her second device and she has never had any issues.The patient reported that she noticed she had been getting a burning sensation around the implant.The patient reported that this started about a week ago and lately it had been more often.The patient reported that yesterday all day, it was bothering her when she sat on her ¿butt¿ it hurt where the implant was.The patient reported that the burning was not directly on the implant, but it was near it.The patient reported that if she touched a certain area, she felt the burning.The patient reported that she ¿has so many pains.¿ the patient reported that her managing doctor had also been giving her injections in her back.The patient reported that on the day prior to the report, she increased and decreased stimulation with the patient programmer (pp).The patient reported that the physical therapist had been giving her an ultrasound on her hips.The patient reported that they did know she had an implant.The patient reported that she went last friday and they recommended she talk to her doctor about if the device needed to be turned off.The patient reported that she was almost positive the burning started after the ultrasound.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: 7663743
• MDR Text Key: 113517915
• Report Number: 3004209178-2018-15031
• 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
• Report Date: 07/05/2018

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: 09/14/2017
• 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: 07/02/2018
• Initial Date FDA Received: 07/05/2018
• Date Device Manufactured: 03/22/2016
• 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: 61 YR