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

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Headache (1880); Unspecified Infection (1930); Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 977a290, serial# (b)(4), implanted: (b)(6) 2016, product type: lead; product id 977a290, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with a neurostimulator.It was reported that an issue occurred post-operation.The symptoms started the day after surgery ((b)(6) 2016) however the patient did not call the health care professional (hcp).The patient had a post-operative appointment on (b)(6) 2016 in the hcp office where they relayed the symptoms.The patient reported that they remembered using the bed pain post-surgery and got a really sharp, intense jolt that did not feel right.The patient felt that this was when all of the symptoms started.Impedances were checked on (b)(6) 2016 and were all okay.The stimulator was reprogrammed and a follow-up appointment to see the hcp was scheduled for (b)(6) 2016.The issue was not resolved at the time of the report.The patient had several complaints.The patient presented no relief in the left elbow pain with the stimulator.They complained that the pocket site was extremely sore and occasionally they would get jolts of pain back there that would radiate down to their right leg to their foot.It did not matter if the device was on or off.The patient also had the complaint of severe headaches since implant of the stimulator, especially when it was on.The stimulation was reprogrammed in high density mode 450/420.At the time the patient was feeling stimulation slightly in their left elbow where they needed it.The patient was also having whole body sensation on the left side which was hard for them to explain when the stimulator was shut off.The patient was instructed to turn the device off until the appointment on (b)(6) 2016.

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 manufacturer representative on 2016-11-18 reporting that the patient saw the health care professional (hcp) on (b)(6) 2016.They had the stimulator turned off to see if that made any difference.The patient continued to have pocket pain and right leg pain that went down to their foot.Also the patient continued to have headaches.The health care professional (hcp) started the patient on antibiotics.The hcp stated that the incisions looked good and the white blood cell count was okay.The hcp was having the patient back on (b)(6) 2016 for epidural injections.The hcp told the patient that the symptoms were not related to the stimulator.With regards to the coverage from the stimulator, the patient was feeling it in their left elbow where they needed it.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6100502
• MDR Text Key: 59902265
• Report Number: 3004209178-2016-23935
• 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
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Date Device Manufactured: 09/20/2016
• 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): Required Intervention
• Patient Age: 51 YR