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

Model Number 97714

Device Problems Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/01/2016

Event Type  malfunction  

Event Description

Information was received from a family member of a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that there was a loss of therapy that occurred on the day of the report,and the patient was only feeling stimulation on their right side.There was no trauma or fall associated with the issue.It was reported that the patient went to the emergency room because the stimulation was malfunctioning because the screen freezes.Something was malfunctioning on the day of the report.The patient had an appointment with the manufacturer representative and health care provider scheduled for (b)(6) 2016 to see if they can adjust programming to resume adequate therapy.

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 received from the manufacturer¿s representative (rep) reported the consumer lost stimulation pain coverage for their left leg more than 6 months ago.

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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6153569
• MDR Text Key: 61729611
• Report Number: 3007566237-2016-04311
• 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
• Report Date: 03/10/2017

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: 02/14/2016
• 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: 11/29/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided; 03/02/2017
• Supplement Dates FDA Received: 03/10/2017; 09/27/2017
• Date Device Manufactured: 03/20/2015
• 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 Age: 17 YR