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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Incontinence (1928); Nerve Damage (1979); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 977a260 serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: (b)(4) 2020, (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: (b)(4) 2020, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was in an automobile accident a few weeks ago and later stated it was on march 6, 2018.The patient stated he spent 4 days in the hospital, was in the emergency room, and then urgent care.The patient mentioned wanting to try a pain pump because the ins was not working for him.The patient stated the stimulator was ¿relieving¿ for the past 8 months, but he had problem with the stimulator since the accident.The patient clarified when he said the unit wasn¿t working that he was referring to the lead not hitting the right areas, and the leads are uncomfortable.The patient stated he could feel both of them when he puts his back against something.The patient said they wanted a pain pump but didn¿t want to continue taking pain medications.The patient stated he was pooping himself and was taking zofran and was on heavy narcotics.The patient said he would rather have something do it for him than continue to take medications himself.The patient mentioned removing the stimulator.The patient inquired about next steps to getting a pain pump.The patient said he was going to pull the stimulator out of his body.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the patient was kicked out of the healthcare provider¿s (hcp) office.The patient said they don't want the machine anymore and said that he could pull the machine out himself.A list of hcp's was sent to the patient.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on 2018-03-30.It was reported the patient was in a accident a few weeks ago and his stimulator quit working.The patient stated he is planning on having the stimulator removed and have implanted pump.The patient was redirected to their healthcare provider.

Manufacturer Narrative

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 was in need of a manufacturer's representative (rep) at their next appointment.The patient stated that they were in an accident and the unit is not working properly.The patient stated that they think the lead shifted and the need the issue solved immediately.The device is only working in the patient's torso, which is not where they need the therapy.No further complications were reported or anticipated.

Manufacturer Narrative

Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017, product type : lead, product id: 977a260 serial# : (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer on 2018-may-01 reporting that that the automobile accident injured the implanted unit and it was not working properly.The lead shifted and was not doing anything for neuropathy it was only working and giving stimulation in their torso (thoracic spine) which was not where the patient needed therapy.It was reported that it felt like they were going to blow out of their chest.Additional information was received from a manufacturer representative on 2018-may-01 noting that their colleague met with the patient last week and their stimulation had been fine.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported they need help getting their stimulator fixed because they were in a car accident on (b)(6) 2018.They stated they would be meeting with a surgeon on (b)(6) 2018, and would like to try reprogramming the device because they were currently not getting any relief, their lower back was burning, they were experiencing a lot of pressure, and their nerve damage was really bothering them.They reported they were using a tens unit to help them until they can get their device fixed.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the patient on (b)(6) 2018.The patient stated that they were not feeling good to talk right now but they were going to get the device fixed.They had an accident which is what messed up the device and they were going to have that taken care of and could not talk at this time.They did not want to talk and continued to say they were going to get the device fixed.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received 2018-10-29.It was reported that mri compatibility guidelines were requested.Overdischarge was suspected.The patient was in a car accident.Therapy stopped at that point and the patient has not maintained the ins since that time.The device has not worked since the car accident.No further complications were reported/anticipated.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a friend/family member of a patient on (b)(6) 2018.The caller was calling to follow up on the case.The caller stated that they were trying to determine what facility they could have the patient meet with someone at to charge the ins.In (b)(6) 2018 there was a car accident where they were hit by a car and then in the emergency room (er).The stimulation was not working at that time and they feel like it wasn't working the same way because of the accident.They were seeing someone at a hospital.The last time the device was working was in (b)(6) 2018.Technical services reviewed information about charging the ins after it has been depleted and reviewed the policy about reps meeting the patient in a healthcare professional (hcp) office.No further complications were reported/are anticipated.

• 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: 7382608
• MDR Text Key: 103862697
• Report Number: 3004209178-2018-06022
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2018
• Date Device Manufactured: 12/22/2016
• 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 Outcome(s): Hospitalization
• Patient Age: 26 YR