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

Model Number 97702

Device Problems Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was receive from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was requesting assistance for their device because the hand thing/remote was not working.According to the patient everything was dead.It was reported that ¿it¿s not working (confirmed referring to the implant battery), like everything went dead¿.It was stated that ¿the programmer was completely dead and not doing anything¿.The patient noted that they were in the process of moving and they had been in so much pain.They stated the pain comes even when the implant battery was working.The pain comes off and on.The patient stated the pain has been there and they just went to the doctor the other day.The patient stated they were getting injections on monday and stated they got injections every three months.The patient reported that they were ¿hurting really bad¿ and they were in ¿a lot of pain¿.It was reported that the implant battery not working began about a week ago in (b)(6) 2018.It was asked but was unknown when the pain began, the patient stated they had pain their whole life.They confirmed this was why they got the implant.Patient services was unable to confirm the event date of the pain the patient was having since they noticed they were in so much pain.The patient reported that they were unable to power up their programmer because it was completely dead and not doing anything and will not power on.The patient confirmed that they were using super heavy-duty batteries.The patient confirmed that they did not have any alkaline batteries to try at the time of the call.The patient stated if the programmer would go dead on them they would check the batteries to see if they needed to replace them, but the programmer was not accepting the batteries they replaced.It was reviewed to have the patient try to change the programmer batteries with brand new aaa batteries, but the patient was unable to try this on the call due to a lack of batteries.There was no out of box issue reported and no medical or therapy issue related to the small parts component.It was indicated that the patient would call back with regular alkaline batteries tomorrow for further troubleshooting.The event occurred in may 2018.Device registration tried to do a warm transfer to redirect the patient to patient services but the patient was disconnected.An outbound call was made to the patient for further assistance.The patient stated they did not have alkaline batteries during the call earlier, but now had alkaline batteries for further troubleshooting.Patient services asked the patient to take out the alkaline batteries and put them in to the programmer.It was indicated that patient services had a lot of difficulty troubleshooting with the patient since the patient got confused with locating the patient programmer and taking out the batteries.It was asked if someone was with the patient that could help them, but they did not.The patient repeated that the programmer was not working.Patient services tried several times to instruct the patient to remove the battery compartment cover and take the alkaline batteries out of the pack and put them into the programmer.The patient stated they could not do it.They said they didn¿t want to remove the compartment cover off.It was reviewed that the compartment cover needed to come off to put the batteries in and power on the programmer.It was asked if the patient could call back when their family visited them for further help.The patient stated they had had the ins for quite a few years now and all the other times ¿this had done that¿ they had someone meet them at their hcp¿s office for further help.Patient services reviewed the role of the manufacturer representative (rep) and redirected them to their hcp if they wanted to get in contact with them.Patient services offered to reach out to repair to see what they could do and asked repair if they could send the patient a replacement controller cause they had this for they think ¿over 30 years).The patient reported to repair that the programmer was not working and they couldn¿t open the battery door so they can¿t read the serial number.No further complications were rep orted/anticipated.

• 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 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7606859
• MDR Text Key: 112155661
• Report Number: 3004209178-2018-13569
• 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: 06/15/2018

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: 05/28/2015
• 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: 06/13/2018
• Initial Date FDA Received: 06/15/2018
• Date Device Manufactured: 12/04/2013
• 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