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

Model Number 97714

Device Problems Failure to Interrogate (1332); Unintended Collision (1429); No Device Output (1435); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Weakness (2145); Ambulation Difficulties (2544)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had 2 implantable neurostimulator (ins) implants and neither one of them could be turned on.It was stated that the patient had been without them for 3 months.The newer ins was for their lower half and the older ins was for their upper half.The reposition antenna screen was on the implantable neurostimulator recharger (insr) and poor communication screen was on the patient programmer.They were not able to communicate to the ins using the insr.The last successful recharge session was last month in (b)(6) 2017 because the patient had been ¿crazy¿ and busy.This has happened in the past.The patient had been dealing with pain since 2003 and still took medications like neurontin.The patient was going to call their primary care physician to have a manufacturer representative paged.Additional information was received from the patient.The patient stated that her ins can¿t turn on and that it won¿t communicate, so she is unable to charge it.The patient stated that this was probably her fault though, because they haven¿t been working in a while and she had a lot going on.The patient further reported that she had been falling a lot and she took a really good fall a few weeks ago and she is having bad back pain, muscle spasms and they feel like charlie horses in her back.The patient stated she could be just sitting and it would happen, "it was happening not that frequently, but now it is happening more frequently".The patient stated she is not sitting too much, not standing too much, and explained that she can try to walk them off but sometimes it just hurts and she can't.The patient stated she is unsure if something has been moved.The patient stated that this may be related to surgery and the stimulators not being on.The patient has fallen a lot more than usual in the last 6 months and she is concerned about it.The patient explained that if she is kneeling down she has to hold something to get standing up again.The patient stated that she thinks now "everything is getting weak" and her "bones are weak" and this may be related to surgery and the stimulators not being on.The patient was redirected to their healthcare provider and it was recommended that the ins be interrogated due to the fall.The indication for implant was spinal pain.

Event Description

Additional information was received from the patient reporting that they were suppose to meet a manufacturing representative at the doctor's office to do a reboot today at 9am.However, they reported that they were there, but the office was closed.It was reported that a different manufacturing representative was suppose to meet the patient, but that they didn't know the office was closed in the morning.They were trying to get a hold of the patient, but they didn't have a good number to reach them at.The manufacturing representative got the patient's cell number and was going to call them back.No further complications were reported/anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.The patient reported that they were having "major issues" and that they needed to speak to a manufacturer representative.The patient reported that both of their inss were totally dormant and dead and that they can't charge them and that it was their fault because they had put their health aside due to some family issues.The patient was upset because they wanted to see a manufacturer representative at their doctor's office, but they couldn't because the office was outside of the region that is covered by the representative.No further complications are anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37714, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.

Event Description

Additional information was received from the manufacturing representative reporting that they tried to do a physician mode recharge (pmr) on the right side, but they were getting the device not supported message.Technical services told the rep that the patient was likely using their older recharger on the newer implant, which doesn't have the proper software to start the pmr session on the newer implant.The rep stated that the patient insisted that the newer implant was on the left, although registration showed that the newer implant was on the right.The rep had to get another recharger, since they were currently running a pmr session on the left side too as the patient had two overdischarged devices.Additional information was then received reported that the newer battery was on the patient¿s right side as our records indicated and that was why the older charger wouldn't work.They got the new charger on that one after clearing the power-on-reset (por) on the left battery.It was reported that pmrs were successfully done on both overdischarged units and that they were able to clear both of their pors.As of that afternoon ((b)(6) 2017), both batteries were charging and seemed to be working.No further complications were reported/anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.The patient reported that one of their inss had been discharged for about 6 months and reported that the other one had been discharged for "i don't know how long"; the rep reported that it had been around 3 years.It was reported that a manufacturer representative was able to meet with the patient in the hallway outside of the doctor's office on (b)(6) 2017.It was reported that the doctor had changed their friday hours the week before, so no one was there.They were not able to address the discharged inss at that meeting.The patient was upset because they had been slighted by representatives in the past.The manufacturer representative was able to calm the patient by the end of the meeting and scheduled an appointment for the patient to meet with someone to have their inss restarted the next week.No further complications are 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, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6447496
• MDR Text Key: 71327176
• Report Number: 3004209178-2017-06726
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Date Device Manufactured: 07/16/2014
• 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: 51 YR