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

Model Number 97714

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

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

Event Date 06/08/2016

Event Type  Injury  

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

The patient via a manufacturer representative reported that they lost stimulation on their right side the night prior to the report while laying down.Impedance measurements were taken and electrode combinations 0-1 and 0-2 showed 37,197 ohms while combination 0-3 showed 35,000 ohms.No matter how they programmed electrodes 0 through 3 the patient did not feel stimulation.The other combination impedances were: 0-4: 36,331 ohms 0-5: 36,331 ohms 0-6: 35,319 ohms 0-7: 35,919 ohms when they looked at contacts 4, 5, 6, and 7 in reference to contacts 1 and 2 the impedance values were in the range of 2,300 to 2,795 ohms.When they looked at the same reference contacts with electrodes 3 through 7 all of the impedances were in the normal range of 660 to 1,000 ohms.The implantable neurostimulator (ins) was on at the time of the report and there were no falls or trauma associated with the issues.The group impedance was taken with 0-1-2-3+ and the group impedance was 1,374 ohms.They were unable to program around the impedance issue.The patient was having a revision surgery on (b)(6) 2016 and it was noted that they may replace the pocket adaptor, extension, or the ins.It was unlikely that they would change the leads because they would defer that to a neurosurgeon.The patient was implanted for lumbar radiculopathy and non-malignant pain.

Manufacturer Narrative

Other applicable components are: product id: 97714, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 74002, product type: adapter.Product id: 3550-29, product type: accessory.Analysis results were not available as of the date of this report.(b)(4).

Event Description

The patient via a manufacturer representative (rep) reported that they were seen at the healthcare provider's office on (b)(6) 2016.It was reported that the right side stimulation had turned off and they were unable to reestablish the right side stimulation during the office visit.Based on impedances, it was determined that it could be a screw loose or possible problem with the extension adaptor.The patient had a lead revision on (b)(6) 2016.The implantable neurostimulator (ins) and adaptor were replaced but they were still unable to reestablish the right side stimulation.There was a report that the patient was seen at the healthcare provider's office shortly after the revision to discuss the paddle implant versus pump trial.

Manufacturer Narrative

Concomitant medical products: product id 97714, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.Product id 74002, product type: adapter.Product id 3550-29, product type: accessory.Analysis of the implantable neurostimulator (ins) [s/n: (b)(4)] found no significant issues.Analysis of the adaptor [s/n: unknown] found the 0 and 1 wires were broken 3.3 cm from the proximal end and there were multiple screw marks.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 from the manufacturer representative that between the health care professional (hcp) and the patient, they decided to try a pain pump instead of doing a lead revision.The patient had a successful pain pump trial.The patient currently had good pain control.

Manufacturer Narrative

(b)(4).

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5798163
• MDR Text Key: 49650048
• Report Number: 3004209178-2016-14297
• 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: 10/27/2016

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: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 10/26/2016; 10/26/2016
• Supplement Dates FDA Received: 08/02/2016; 09/02/2016; 09/30/2016; 10/27/2016; 09/24/2017; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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: 42 YR