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

Model Number 97714

Device Problems Energy Output Problem (1431); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Malaise (2359)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient had been to the emergency room a few times due to severe pain at the implant site.The pain started in (b)(6) 2017.It was severe on the night of (b)(6) 2018, and she ended up in the emergency room.The patient said that they thought that it was her kidneys, but now think it is the device.The patient¿s blood pressure was ¿sky high¿ (158/94) and typically it is 120/80.They had to give her two doses of morphine for the pain.She has turned stimulation off and still has pain at the implant site.The patient has an appointment scheduled with her health care provider for (b)(6) 2018.Additional information was received from a consumer and a manufacturer representative on (b)(6) 2018.It was reported that there was pain at the implantable neurostimulator site when the implantable neurostimulator was on.Patient stated when the implantable neurostimulator was off, the pain went away.The manufacturer representative was unable to program around the issue.The manufacturer representative stated that the impedances looked good.Additional information was received from a manufacturer representative regarding the patient on (b)(6) 2018.It was reported that the cause of the patient feeling pain at the implant site when the implantable neurostimulator was turned on was not determined, and that there were no impedances to verify a shortage or malfunction of the unit.The pain over the implantable neurostimulator site went away after several hours.It was likely that the patient would have a battery replaced with a new system in the second half of march.Additional information was received from the manufacturer representative regarding the patient on (b)(6) 2018.It was reported that the patient is wanting to pursue either having the entire spinal cord stimulation system removed or having the spinal cord stimulation system replaced due to the pain they were feeling at pocket site that persists with stimulation off and on.The manufacturer representative noted that even when stimulation had been turned off without patient knowing during clinic visit, the patient still complained of pain and asked for stimulation to be turned off.The therapy was and has been helping patient's low back and leg pain and has not changed since the pocket pain began.Currently, patient is leaving stimulation off, and patient is back to their baseline pain level due to stimulation being off.The patient thought that something was wrong with their spinal cord stimulation system.The manufacturer representative noted on (b)(6) 2018 that there is no way of knowing if there is something wrong with the spinal cord stimulation system as all device impedances looked normal.The patient noted that she only has pain upon turning the device on, and had elected to have the device removed/replaced.A surgery is being scheduled to do so.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported the ins was removed on (b)(6) 2018.The patient wanted to send the device in for analysis to make sure nothing is wrong with it as the patient was convinced her pain was from it malfunctioning.The hcp didn't see anything out of the ordinary in the pocket upon removal, and they did not believe the device had anything to do with the supposed pain situation.No further complications were reported.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the patient had sever pain at the ins site and they went to the er on (b)(6) 2018.The patient could not turn the device on without sharp pain near the battery.Impedances all looked normal.No further complications were reported.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Analysis of the implantable neurostimulator (s/n (b)(4)) found that the battery had a reduced capacity due to overdischarge.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.It was reported that the patient's ins was removed because it was "leaking ionic (battery) fluid.The patient stated that they didn¿t get the lead removed because they didn't want the risk of uncoverable spinal damage.The patient stated that they had noticed that they were in a lot of pain and had become very sick so they went to the er and this is where it was discovered that the battery is leaking.The patient stated that he emergency room told them that they wanted to remove the battery right then, but the patient waited until their implanting healthcare provider (hcp) was available to come and remove it.The patient stated that they had the "paper work" to prove it.The patient reported that they were calling to have the manufacturer pay for the explant.No further complications were reported or anticipated.

Manufacturer Narrative

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7441924
• MDR Text Key: 105874269
• Report Number: 3004209178-2018-08358
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 09/19/2018

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: 02/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 06/04/2018; 08/03/2018; 09/17/2018
• Supplement Dates FDA Received: 06/06/2018; 06/11/2018; 08/09/2018; 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR