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); High impedance (1291); Device Operates Differently Than Expected (2913)

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

Event Date 08/30/2016

Event Type  Injury  

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.

Event Description

Information was received from a consumer via a manufacturer's representative (rep) regarding a patient who was implanted with a neurostimulator for radiculopathy and spinal pain.It was reported the patient had a loss of therapy and her stimulation was very positional.It was noted that the patient was very active and environmental/external/patient factors that may have led or contributed to the issue included hiking, running, and horseback riding.Diagnostics/troubleshooting performed included impedance checks as well as a group impedance check, which found that the patient's one program and electrodes 5 and 15 were not functioning properly.Electrodes 5 and 15 had impedances >20,000 ohms.Interventions/actions taken or that would be taken included this information being given to the patient's healthcare provider (hcp) and the patient noted that she would get back to the rep after a two week backpacking trip.The issue was not resolved at the time of the report.The patient's status at the time of this report was "alive with no injury." surgical intervention had not occurred at the time of this report and it was unknown if surgical intervention was planned.

Event Description

Additional information reported by the patient via the manufacturer representative stated that the stimulator has shut off twice by itself.It was reported that after charging the stimulator at night, it shut off by itself.It was reported that the patient was programmed around the fail electrodes to give adequate coverage for the chronic pain.There was no positional stimulation, just not effective therapy, as the programming was using 5 and 15.Patient has dual lead revision scheduled in (b)(6).

Manufacturer Narrative

Correction: upon further review intervention required applies, and serious injury applies.Conclusion code applies to the leads (serial # (b)(4)).

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Product id 977a26, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Corrections.

Manufacturer Narrative

Analysis of the lead (va10mrl002) found reliability non-conformances on the stimulation lead.It was found that on electrode 4-6 the stimulation lead body conductor was broken at the anchor site.Analysis of the lead (va10mrl001) found reliability non-conformances on the stimulation lead.It was found that on electrode 4-7 the stimulation lead body conductor was broken at the anchor site.

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.

Manufacturer Narrative

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.

• 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5981999
• MDR Text Key: 55789273
• Report Number: 3004209178-2016-19852
• 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,Followup,Followup
• Report Date: 01/12/2017

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: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 01/11/2017; 01/11/2017
• Supplement Dates FDA Received: 11/08/2016; 12/07/2016; 12/07/2016; 01/11/2017; 01/12/2017; 09/26/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 43 YR