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

Model Number 97714

Device Problems High impedance (1291); Energy Output Problem (1431); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturing representative reported that they suspected a malfunction of software or hardware.During a follow up appointment the patient reported that since a few weeks the stimulation (all programs, all locations sub-q and spinal cord stimulation (scs) leads) did not feel like before.The paresthesia felt like uncomfortable knocking.The manufacturing representative stated that they would expect such a sensation when programming very low frequencies below 40 hz, but that was not the case.They tried some reprogramming and suddenly after programming a program up to 195 hz and she felt again the comfortable paresthesia she had before.Also with the other programs (programming remained unchanged) the paresthesia sensation was back to ¿normal.¿ before being back to ¿normal¿ the manufacturing representative received a strange message sometimes on the physician programmer screen during reprogramming.This message appeared when they programmed the frequencies from 130 to 80hz.The manufacturing representative stated that there was a mismatch between the programmed frequencies and the frequency delivered by the stimulator.It was also noted that the message on the physician programmer indicated that it was mandatory to set the amplitude to 0.0 volts (for all programs) before changing the frequency to avoid unpleasant stimulation.This message will always appear if you would like to change the frequency while stimulation is on and the voltage is set to values higher than 0v.So far the issue was resolved.The device data was reviewed and no anomalies were seen apart from the high impedances on the electrodes which were not used.There was no power on reset (por) message.The stimulation was off for most of the time.The patient often turned the stimulator off due to uncomfortable paresthesia.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported that the patient could not mention an exact date they began experiencing the issue; the patient stated a few weeks ago.The cause of the problem was not determined.The problem did not occur again and the issue was resolved.It was noted that this information was confirmed with the physician/account.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that the problem seemed to be solved after reprogramming to higher frequencies.On (b)(6) 2019, the patient was in the hospital for follow-up and reported the same strange device behavior.There was a sudden change in the sensation of paresthesia around two to three months prior.The patient couldn't use program b, c, and d anymore because they were hammering/inconvenient.At the same time, the patient got a por message from time to time on their patient programmer screen.It was noted that the rep's personal feeling during programming was that when the patient feels a hammering sensation, that the device doesn¿t deliver the programmed frequency, just a fraction of it.What the patient described was what the rep would expect when delivering 10 hertz rate.It was noted that the rep assumed hardware damage.The rep was to provide a device report and data file.Additional information was received from the rep.The report and data file were provided, and it was noted that the rep would see the patient and physician on (b)(6) 2019.The report showed that there was high impedance greater than 10000 ohms measured on electrodes 3, 4, 5, and 10 using electrode 0 as the reference.From therapy settings, it was noticed that there were programmed groups that used the electrodes showing high impedance.Review of the data file did not detect any anomalies and it was noted that no por event was recorded.Additional information was received from the rep.It was reported that the rep did some reprogramming on 06-mar-2019.The patient mentioned that they had the hammering sensation again with all programmed groups except group a.Finally the sensation was always comfortable.The rep hoped that the issue was now resolved.It was noted that reprogramming was done to avoid the electrodes with high impedance.The sensation was associated with the left leg, paresthesia on the right leg was never affected.There were no known falls or accidents before the appearance of these symptoms.It was noted that the patient had two previous implantable neurostimulators with primary cell batteries, one implanted in 2010 and the other implanted in 2012.

Event Description

Additional information received reported that the patient¿s device was replaced.No further complications were reported or anticipated.

Manufacturer Narrative

Product id: 3708220, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 3708220, serial# (b)(4), product type: extension; product id: 3888-45, serial# unknown, product type: lead; product id: 3550-39, lot# unknown, product type: accessory; product id: 3888-33, serial# unknown, product type: lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 3708220, serial# (b)(4), product type: extension; product id: 3888-45, serial# unknown, product type: lead; product id: 3550-39, lot# unknown, product type: accessory; product id: 3888-33, serial# unknown, product type: lead.Analysis of the ins (s/n: (b)(4)) found that the device was functionally okay with insignificant anomalies.Analysis of the lead (s/n: unknown) found the distal end conductor to be broken.Analysis of the lead (s/n: unknown) found the distal end weld to be corroded.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 7659400
• MDR Text Key: 113203314
• Report Number: 3007566237-2018-01963
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/15/2020

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: 04/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR