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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Malaise (2359)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead. 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 family member of a patient who was implanted with a neurostimulator for spinal pain and failed back surgery syndrome. It was reported on (b)(6) 2016 that the patient¿s implantable neurostimulator (ins) didn¿t work and that the healthcare professional (hcp) put the leads in the wrong place. It was noted that during the implant, the patient was on their stomach (sedated) and felt the stimulation ¿good¿. But once they got up and the sedation wore off, the stimulation was on the wrong side and they did not feel any relief. The manufacturer representative worked hard to try to reprogram the device to get stimulation to the correct side but was not able to. The patient was still implanted with the device but was not using it. The patient was to have an mri and the family member was able to program it into the mri mode. Additional information was received from a family member of the patient on (b)(6) 2016 that reported that the device never worked since the day of implant and they put the leads in the wrong place. The patient has since been ill and now needs a mri. Since the patient has been ill, he cannot get it out. It has been in so long and it is not being used. The health care provider said that he could not do anything to correct it.

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6150979
• MDR Text Key: 102432248
• Report Number: 3004209178-2016-25318
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial