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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/19/2016

Event Type  malfunction  

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

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain and chest wall stimulation.It was reported that the patient had a loss of stimulation.The caller reported that the stimulator stopped working a month ago.The patient wasn't getting stimulation, so they met with the manufacturer's representative's (rep) assistant.The assistant tried to reprogram the ins and got only part of the stimulation to work.The caller reported that the stimulation wasn't where it needed to be.The caller stated that the patient left the stimulation on anyways.The caller and patient couldn't get the device to work properly so they made a doctor appointment.The patient went to the appointment and got an x-ray which showed no issues with the leads.The rep wants to see the patient again, but can't meet until late next week.The rep wants to schedule the patient to see them, then to go back to the surgeon, and see the rep again.Additional information received from a contact indicated that the patient will undergo battery replacement on (b)(6) 2016.

Manufacturer Narrative

(b)(4).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

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain and chest wall stimulation.It was reported that the patient had a loss of stimulation.The caller reported that the stimulator stopped working a month ago.The patient wasn't getting stimulation, so they met with the manufacturer's representative's (rep) assistant.The assistant tried to reprogram the ins and got only part of the stimulation to work.The caller reported that the stimulation wasn't where it needed to be.The caller stated that the patient left the stimulation on anyways.The caller and patient couldn't get the device to work properly so they made a doctor appointment.The patient went to the appointment and got an x-ray which showed no issues with the leads.The rep wants to see the patient again, but can't meet until late next week.The rep wants to schedule the patient to see them, then to go back to the surgeon, and see the rep again.Additional information received from a contact indicated that the patient will undergo battery replacement on (b)(6) 2016.Additional information was received from a manufacturer's representative stating that the rep saw the patient before (b)(6).The representative stated that the patient has high impedances in the lower left quadrant.The rest of the lead is fine and the battery is good.The representative stated that the challenge is that the 4 electrodes with high impedance may serve the patient with the best therapy.

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: 6122380
• MDR Text Key: 60742188
• Report Number: 3004209178-2016-24590
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

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: 08/28/2015
• 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: 11/09/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; 09/16/2016
• Supplement Dates FDA Received: 12/13/2016; 09/27/2017
• Date Device Manufactured: 10/10/2014
• 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: 41 YR