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

Model Number 97714

Device Problems Energy Output Problem (1431); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial# (b)(4), implanted: (b)(6) 2017, explanted: product type implantable neurostimulator.It was noted that the patient had 2 implantable neurostimulators (ins) present during the event.See manufacturer¿s report # 3004209178-2018-11286 for the concomitant ins information.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative regarding patient's neurostimulator (ins) that was implanted for spinal pain and non-malignant pain.It was reported that patient feels pulsating sensation in his ins pocket area when he lies on that area and when he bends over.The pulsating is like a heartbeat.Patient has been using hd programming and his current hd settings for a long time.Patient usually doesn't feel stim with his hd settings, though sometimes he can feel a light tingling.Caller tried programming ld settings today but this didn't resolve the issue.Patient does not feel sensation with stim off.Palpation of ins area with stim on did not create any changes in stim.Patient does note that when the pulsating is occurring that his stimulation does feel different.Impedances taken with patient in position that causes this pulsating did not reflect any changes in impedances.(initial check of imped did show "xxx" on all pairs with 0 except #13, which showed 2950 ohms).Caller remeasured impedances and then these values normalized.No trauma/falls were reported that could be related to this issue.Patient can turn the stim down and then this pulsating isn't felt as strongly, but then patient doesn't get the pain relief he needs when using lower voltage.The pulsating issue started in (b)(6) 2018; an exact date was not provided.They will keep an eye on the issue for now.No further complications were reported/anticipated.

Manufacturer Narrative

Additional information indicated that the device associated with the complaint originally reported was captured in regulatory report (b)(4): product id (b)(4) serial# (b)(4) implanted: (b)(4) 2017: product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Manufacturer¿s report was incorrectly submitted on this device.There is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned and does not meet the reporting requirements stipulated in 21 cfr 803.Please see the correct manufacturer¿s report # 3004209178-2018-11286.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.Caller stated that after initial troubleshooting and patient had time to experience updated programming.Caller stated no changes as a result and requested advice on next steps and confirmed that patient could not turn up stimulation to get pain relief.Caller was advised to run additional impedance tests in different positions, reprogram stimulation and possibly obtain imaging to look for damaged leads and discuss next steps with the managing physician.No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: 7526331
• MDR Text Key: 109004462
• Report Number: 3004209178-2018-11289
• 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,Followup
• Report Date: 10/04/2018

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: 09/28/2017
• 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: 05/16/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 06/28/2018; 06/28/2018; 08/08/2018
• Supplement Dates FDA Received: 06/06/2018; 07/10/2018; 07/10/2018; 10/04/2018
• Date Device Manufactured: 11/07/2016
• 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 Age: 49 YR