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

Model Number 97714

Device Problems Overheating of Device (1437); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Swelling (2091); Burning Sensation (2146); Distress (2329); Complaint, Ill-Defined (2331); Injury (2348); Depression (2361); Weight Changes (2607)

Event Date 04/16/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product type: recharger.(b)(4).See manufacturer¿s report # 3004209178-2016-04098 for the previously reported device issue.

Event Description

Information received from the patient reported that 5 days prior ((b)(6) 2016) they were in a chair recharging for about 2.5-3 hours and it got ¿super hot¿ in about a 30 second time frame span.The also had discomfort while recharging.They got a ¿horrible¿ big burn on their back where the implantable neurostimulator (ins) was.There was swelling (the size of a half baseball) at the ins site.The patient immediately put ice packs on it and got the swelling down.It was noted that the ins was functioning but they had a ¿horrible¿ black circle on their back at the ins site.The patient was scared that the ins battery is expanded and wanted the recharger replaced immediately.Additional information received from the healthcare professional via the manufacturer¿s representative reported that the patient was seen by the hcp staff on (b)(6) 2016 where it was noted that they had a superficial burn to the area of their ins site.The skin was not broken or blistered but was definitely burned.No interventions were performed at the time.No surgical interventions occurred or were planned.Further information received on may 17, 2016 reported that the patient was told not to turn on the ins device because of a hematoma present due to the burn.The patient had an appointment with their doctor and the manufacturer¿s representative on (b)(6) 2016.The indication for use for the implanted device was noted as spinal pain.There were no further details, troubleshooting, interventions, or an outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

The manufacturer representative (rep) met the patient today and noted that the patient had not turned on the implantable neurostimulator (ins) or charged it since the issue was reported.Impedance tests were performed and a general range of 700-1100 ohms was reported, and stated all impedances looked good.It was advised that having the ins on versus off was not going to produce a discernable change in temperature in the patient's pocket.It was recommended that the patient consider using the belt or spacer, consider a shorter recharge session, and not charge while sitting in a chair as that may exacerbate the situation.On (b)(6) 2016, the patient reported a serious malfunction; burned him horribly by the implantable neurostimulator (ins).The patient had an appointment on friday with the physician and the manufacturer representative (rep).The physician refused to turn the ins on.The patient stated that the rep checked the ins and the rep stated that he believed the ins was okay.The physician disagreed and stated that the ins needed to be replaced and placement changed.Additionally, having the ins analyzed following explant was reviewed.The patient stated it would be analyzed by an independent lab.The patient noted getting an attorney, was provided the contact information for the legal department.On (b)(6) 2016, the rep reported that she was called to be present at the appointment with the neurosurgeon.The patient stated that the manufacturer had agreed to pay for a replacement.The rep had no information about this and noted that the patient was currently not scheduled for any replacement.

Event Description

Additional information reported that the patient had a replacement procedure scheduled for friday.The patient stated that they were going to place a new device system on their opposite side and try to remove the hematoma.They also reported that they were in so much pain that it caused them to be sick and vomit.It was noted that the patient's spouse had to give them "heimlich" on multiple occasion's event though they were eating "mush" (cream of wheat and ice cream).The patient mentioned that they had gained 20 pounds and now had to have surgery on their throat because it was "shrinking" due to all of the vomiting (which was due to the pain).

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 received from the manufacturer's representative reported that the patient had their ins replaced due to a "burning in the pocket during recharging".It was noted that the patient was to be sent a replacement recharger but all they received was the ac adaptor.The patient was getting ready to start charging their new ins following the healing time from the replacement surgery.A replacement recharger was requested.

Manufacturer Narrative

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

Manufacturer Narrative

Review of this mdr and additional information received showed that a duplicate report, 3004209178-2017-23409, had been submitted for this event.Please refer to this report, mfr report # 3004209178-2016-09733, for all information regarding this event and any further information received regarding this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a legal representative.It was reported that the patient suffered from chronic back pain, and to help this condition was the reason that the patient's neurostimulator was first implanted.On or about (b)(6) 2016, or shortly thereafter, the patient's product malfunctioned causing a severe burn to the patient's back.The patient's body was burned from the inside to the surface of the skin causing a severe injury.It was reported that the product caused the severe burn which could not have occurred without a defect in the product.It was noted that reps were present with the patient's surgeon who observed the burn in addition to participating it the decision making process that the device could no longer be used and had to be removed and replaced.On (b)(6) 2016, the patient's ins was surgically replaced with a new ins.It was noted that the patient underwent two surgeries for the removal of the old device and implantation of the new unit.It was reported that the manufacturer's product was defective in manufacture and construction, was defective in design and formulation, was defective due to inadequate warning or instruction, and was further defective because the product did not conform to representations made by the manufacturer.It was reported th at the patient suffered general, special, incidental and consequential damages as a direct and proximate result of the acts and omissions of the manufacturer including, but not limited to: damages for general pain and suffering; damages for loss of enjoyment of life, both past and future, past medical and medical-related expenses; future medical and medical-related expenses; travel and travel-related expenses, both past and future; lost wages; emotional distress, past and future pharmaceutical expense, past and future; and all other ordinary, incidental, or consequential damages that would or could be reasonably anticipated to arise under the circumstances.It was also noted that the patient sustained permanent injuries.Additional information was received from the patient.It was reported that the patient was now getting around to sending back the original recharger.

• 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: 5663628
• MDR Text Key: 45420641
• Report Number: 3004209178-2016-09733
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2018

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: 10/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 07/01/2016; 01/02/2018
• Supplement Dates FDA Received: 06/15/2016; 07/07/2016; 07/09/2016; 09/22/2017; 01/18/2018
• Date Device Manufactured: 11/18/2015
• 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: 61 YR