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

Model Number 97714

Device Problems Charging Problem (2892); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Incontinence (1928); Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 10/01/2018

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 consumer regarding a patient implanted with an implantable neurostimulator (ins) for non-malignant pain and post lumbar laminectomy syndrome.It was reported that the patient was feeling pain in their back and thought that their ins might be broken.The patient charged the ins 6-7 weeks prior to the report and stated that it was still fully charged.Later the patient called back with their patient programmer and noted that the ins was off.The patient was able to turn stimulation back on and confirmed it was working.The issue was resolved.Information was received from the patient on (b)(6) 2018 that they had been having diarrhea for the last 12 days and can't keep anything in.The consumer reported that their urologist told them that the lead may be touching his bladder or that they may have a broken modulator.Patient was redirected to hcp and get the check up on the device to make sure everything was okay.It was also recommended that patient try to turn ins off to see if that helped.Patient stated they already tried that.Patient stated that they could not have an mri because they could not sit on their back for 15 minute.Reviewed with patient that hcp should work with them to see if they can get other types of scans like ct, x-ray etc.Additional information was received from the consumer on (b)(6) 2019 reporting that about 2.5 months ago they fell off of a ladder and broke their elbow.While in rehab, they noticed that their battery would not recharge.The manufacturer representative was called and helped turn it on.It was then charged 75% and set to the proper settings.2 weeks later they started having diarrhea.They check the back unit and it showed 75% full.It was noted that "so very little of the unite was working." after 9 days of diarrhea, the patient saw their urologist who felt it might have been caused by the leads touching their bladder, prostate, or something else.The next day the patient saw their primary care physician and then went to the emergency room on the 12th day.The patient got better fluids at the hospital and had not touched their unit for over a week now.They were reported to be doing better on (b)(6) 2018.They took anti-diarrhea medication which stopped it.Additional information was received from the consumer on (b)(6) 2019 reporting that they had been taking oxycodone for the fall and broken bone.The consumer believed that the stimulator was broken.The patient was working on meeting with an hcp to review their device and requested a manufacturer representative be there.The patient had continued bladder and bowel incontinence.It was reported that an x-ray had been performed while the patient was in the er but the hcp had no prior x-ray to compare it to.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: 8276346
• MDR Text Key: 134197619
• Report Number: 3004209178-2019-01700
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2019

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: 09/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/24/2019
• Date Device Manufactured: 11/13/2014
• 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