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

Model Number 97714

Device Problems Intermittent Continuity (1121); High impedance (1291); Unintended Collision (1429); Energy Output Problem (1431); Battery Problem (2885); Device Operates Differently Than Expected (2913); Impedance Problem (2950); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient had 3 cervical peripheral nerve stimulation (pns) leads implanted to cover neck and shoulder pain.Prior to last week, the patient was receiving good pain relief in all of their painful areas of neck and shoulders.The patient had a loss of therapy and left neck pain.It was confirmed that there were no associated falls or traumas.Impedance tests showed electrode 3 was out of range (oor).After reprogramming, the patient could only feel stimulation from their left lead in their left should and nothing in their neck as they had before.An appointment with the health care provider (hcp) was going to be made for an x-ray to rule out lead migration.The other cervical pns lead was implanted in the right side of neck to cover their right side neck pain.It was confirmed that the coverage had not changed there, it was working, and provided right neck pain coverage without issue.The cervical pns lead implanted at the base of the neck to cover should pain had impedance testing return with normal limits and the patient could feel stimulation but now they felt it approximately 2 inches below their painful areas of the neck.Patient weight and medical history were asked but would not be made available.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 consumer.It was reported that since he had fall on cement, he has also felt a false surge go from his neck to the top of his head and behind the eye.It pulses and then it turns off and comes on again.This occurs when the patient is laying down.The patient stated that a rep had shut one of the leads off, but he was still getting the surging in the lead in the left side of his neck.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 the patient and a manufacturer representative (rep).It was reported that the patient continued to have a lot of muscle spasms and pain at the ins explant site.The healthcare professional put the patient on some new medication for the muscle spasms in their neck.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 2019-06-17.It was reported that it was confirmed that there was no infection.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis of the ins ((b)(4)) found no significant anomalies.Below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a patient and a manufacturer representative (rep) reporting that the patient felt sudden surging stimulation (also described later as intense pulsing) in their stimulation area and then the battery loses power and needs to be charged.The patient did not know if the amplitude showed as increased on the patient programmer.It was reported that the patient did have a fall on the battery and they also noted that the pocket was swollen and tender to touch and the patient sometimes felt a ¿tearing¿ sensation in the pocket.The caller added that they checked the impedances and contact 3 was greater than 10,000 ohms, but 3 was not programmed.The patient had cervical/occipital leads.Technical services asked if the issue was positional and the rep stated no.It was reported that imaging had been done and the lead had not moved.The patient was on low dose programming.B1 450pw rate 30 amp 7.4 928 ohms, b2 450pw rate 30 amp 7.4 928 ohms it was reported that the caller attempted some range of motion testing and they were unable to replicate the issue today.It was reported that the doctor was taking the patient back for surgery to look for an infection.It was reported that the fall occurred in (b)(6) 2018 and the out of range impedances were found (b)(6) 2019.Additional information was received from the rep the next day reporting that the surgery was scheduled for (b)(6) and the plan was to remove the patient¿s old system entirely and to send it in for analysis.They were then going to implant a new system with 1x8 leads and a new rechargeable ins as long as the infection was ruled out from the swollen pocket.No further complications were reported/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: 7151287
• MDR Text Key: 96122120
• Report Number: 3004209178-2017-26720
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/15/2019

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: 05/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 04/22/2019; 04/24/2019; 06/12/2019; 06/17/2019; 10/07/2019
• Supplement Dates FDA Received: 04/24/2019; 05/09/2019; 06/17/2019; 06/18/2019; 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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: 47 YR