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); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Skin Erosion (2075); Therapeutic Response, Decreased (2271); Discomfort (2330); Skin Inflammation (2443); Electric Shock (2554)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 977a290, serial# (b)(4), implanted: (b)(6) 2017, product type lead.Product id 977a290, serial# (b)(4), implanted: (b)(6) 2017, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 28-aug-2021, udi#: (b)(4); product id: 977a290, serial/lot #: (b)(4), ubd: 13-mar-2021, udi#: (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 spinal pain.It was reported that the patient had issues with their leads.The patient stated they had two leads that were at the surface of the patient's skin that were electrocuting the patient.During a move, the patient held the handle on the moving truck and fell backwards.About a week and a half after the fall the patient experienced the lead issues and feeling like they're being electrocuted.The patient inquired if there was a way to turn off certain leads in their back.The leads were at c1 to t3 and felt like they had moved an inch away.The patient did not want to turn their stimulation off because then the pain would return.They would be having a ct scan and x-ray on (b)(6) 2018.They have 10 "leads" on the left and right side, it was understood that patient meant 10 electrodes.It was further reported that they were electrocuted again, on (b)(6) 2018, to the point it caused huge blisters on their thumb, index finger, second finger on both hands, and on their palms by their thumb.The blisters had little holes in them and were down to a layer where the skin was raw and almost down to the bone.It was mentioned that they had equipment and one of which required an access code, it was clarified the patient had a recharger and patient programmer.The patient wanted to deactivate leads, so it was reviewed that the patient is unable to control which leads they can turn on/off with their equipment.They had tried all of the patterns a-g and they mentioned something was screwy because something was electrocuting them.The patient was redirected to their healthcare provider for assistance regarding uncomfortable stimulation.No further complications were reported or anticipated.Additional information was received and it was reported that the lead had migrated.The patient had fallen a few days prior ((b)(6) 2018).The patient lost effective therapy and the patient could feel that the leads were closer to the skin.The patient was advised that a lead revision might be necessary.No further complications were reported or anticipated.It was further reported that the patient was in a lot of pain.The patient stated they needed an updated id card.The patient stated that they got their device checked at the healthcare providers office and they were told 3 or 4 leads were active.The patient stated the leads were protruding or almost protruding through the skin.The ins only had 2 leads attached.No further complications were reported or anticipated.

Manufacturer Narrative

Continuation of concomitant products: product id 977a290, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id 977a290, 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 2018-08-08.It was reported the patient was no longer receiving stimulation in needed areas.Per patient the lead has migrated.The patient reported an accident by which he fell when a cart he was pulling came apart.Impedances were within normal limits.Reprogramming unsuccessful to provide desired coverage.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a290, 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

2018-oct-03 - additional information was received from the patient.Patient mentioned previously documented issues that his stimulator got yanked loose from an injury while pulling a flat cart with a u-shaped handle that came off, throwing him backwards, jerking his body into a beam.X-rays were done, and the left side had yanked loose, which was anchored down with multiple anchors from c1 to the battery pack, all the way down his back, and there were different slices where they had put in the anchors and looped the wire.It caught it from falling further, but the left side is not working, and it was shut off because it was shocking him since 2 leads were touching each other.The right side got displaced a little bit away from where it is supposed to be, maybe came off the anchor, and the right side still works mostly but not as good as it did because the leads are split.The neurosurgeon said he can take it out but not put it back in because the hcp said it is considered experimental in consult with a rep.Patient stated the implant had made a night and day difference, that he went from taking 400 mg of dilaudid a day down to 16, and he did it overnight.Patient asked for information.No further complications were reported/anticipate.

• 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: 7597601
• MDR Text Key: 111016965
• Report Number: 3004209178-2018-13337
• 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
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2018
• Date Device Manufactured: 03/20/2017
• 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): Required Intervention
• Patient Age: 44 YR