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

Model Number 97714

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

Patient Problems Erythema (1840); Pain (1994); Seroma (2069); Swelling (2091); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Information was received from a patient via a manufacturer representative regarding that patient who was implanted with a neurostimulator for spinal pain, radiculopathy, and other.It was reported that approximately two weeks prior to the report that the patient developed significant swelling at the battery site.The implanting physician stated that it was a large fluid collection.The patient had a temperature of 103 degrees fahrenheit.No lab work was done, but the patient was started on a course of keflex.The swelling decreased dramatically.The implanting physician ordered one more week of antibiotics, and the patient was going to have lab work drawn 3-4 days after completing the antibiotic course.The patient was seen (b)(6) 2016 by the implanting physician.The site looked better compared to how it was 2 weeks prior.The physician was still concerned and will monitor closely for any increase in swelling again which would result in the physician removing the system.The patient's battery was discharged, so no programming was done to the system.The patient was going home to charge her battery up on (b)(6) 2016.The patient's medical history includes type ii diabetes.Additional information has been requested regarding what caused the swelling, but it was not available at the time of this report.If additional information is received, a follow-up report will be submitted.

Event Description

Additional information received from the manufacturer's representative (rep) reported lab results came back negative for an infection.The original concern was that the implantable neurostimulator (ins) site was painful to the touch and there was swelling at the site when the system turned on.The symptoms seemed to subside when the system was turned off.The battery was turned off since last week and the swelling and pain at the ins subsided.The rep.Was going to try turning the ins on to see if they could replicate the scenario, but the physician wanted the consumer to keep the ins off for two weeks until they returned next week, and then they would turn the battery back on to see if the consumer still had the same complaints.

Manufacturer Narrative

Concomitant products: product id: 3550-29, lot# n501403, implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: accessory.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information received from a healthcare provider (hcp) and a manufacturer's representative (rep) reported the patient complained of swelling and redness at the implant site that was worse when stimulation was on.The patient's system was explanted.It was unknown if there was infection, but cultures of the pocket site were taken on the day of explant.The patient recovered without sequela.

Manufacturer Narrative

The implantable neurostimulator (ins) (serial # (b)(4)) was returned and analysis found the grommet to be loose.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.

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 consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain, radiculopathy, and others.It was reported that patient had their device removed on (b)(6) 2016 because it had a "faulty battery" and the patient stated that they wanted to be reimbursed for the explant.The patient stated that they had an attorney, but then stated it was for something unrelated to the device.The patient information was passed on regarding the request for reimbursement.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the patient through a legal representative reported that following the implant of her device that she had ¿continued to experience significant problems postoperatively.¿ according to the patient, their hcp ¿opined there was an electrical failure with the implant.¿ the patient¿s device was later explanted.

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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5511415
• MDR Text Key: 40726107
• Report Number: 3004209178-2016-04946
• Device Sequence Number: 1
• Product Code: GZB
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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: 00051 YR