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

Model Number 97714

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

A health care professional via a manufacturer representative reported a displacement of the lead, which occurred within three (3) months of implant.Stimulation was to cover the upper and lower limbs; however, the consumer had not felt stimulation of the lower limbs since about one week prior.No possible cause was noted.The consumer went to rehabilitation regularly.At the last rehabilitation, the consumer lied on a waterbed and pressure was applied to the whole body.It was not done in the most recent rehabilitation.At the follow up visit on (b)(6) 2016, telemetry was done and impedance of the lead was measured.(normal value).Output was increased, but there was no response.The position of the lead was confirmed under x-ray images; it showed displacement of the lead.Because the position of the lead displaced largely, the reoperation to change the position of the lead (return to the original position) will be conducted on (b)(6) 2016.The consumer walked slowly on crutches, because they could not feel stimulation due to displacement of the lead (returned to the status before scs).The issue was not resolved at the time of the report.The consumer's medical history included fbss.

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

Concomitant medical products: product id neu_unknown, product type: unknown.Product id neu_unknown, product type: unknown.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

Concomitant products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The company representative (rep) additionally reported that the leads had been implanted in the cervical and lumbar vertebra.The patient visited the hospital complaining the problem of the feeling stimulation of the lumbar side lead.There was stimulation failure in the cervical spine side.The impedance was measured and all electrodes showed normal value.The output was increased to 10.5v, but the patient did not feel stimulation.The x-ray image showed the electrode of the tip of the lead came off from the epidural space and coiled between the skin and fascia.The device settings were : 10.5v, 210pw, normal value impedance 700-1 ,000ohms, 10hz, bipolar, #12 anode, and #13 cathode.The patient got treatment using a water bed at an osteopathic clinic, it was considered that the water pressure was applied to the patient¿s back (waist) and the fixed anchor came off and the lead also came off.Further stated the suspected fracture could occur for the waist.It was also stated that while the patient was taking a body posture where the patient felt stimulation at the pain site, the stimulation was interrupted (broken).Impedances were measured for each body posture.Impedance measurement showed unstable/abnormal for #0 and #6 tip electrodes.#0 electrode was measured as 16,000ohms in some body posture and the patient felt no stimulation at that time.#0 was used at original settings.The device settings were: 2.8v, 210pw, 10 rate, bipolar, anode electrode 0, and cathode electrode 1.There was no issue with stimulation and threshold for combinations using other electrodes.On (b)(6) 2016 the procedure to change the position of the lead was performed, and both of the leads were replaced.Stimulation has been resumed.The issue was resolved at the time of this report.The physician¿s observation about severity was considered severe.The patient was alive with injury.

Manufacturer Narrative

Device analysis for lead (b)(4) revealed no anomaly found.Device analysis for lead (b)(4) revealed the lead body conductor broken (overstressed/damaged).The #0 and #6 conductors are broken 32.0 cm from the distal end.According the event information, the lead had come out of the epidural space and coiled which would have put stress on the lead beyond its intended reliability.(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.

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: 5853355
• MDR Text Key: 51368302
• Report Number: 3004209178-2016-15689
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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: 69 YR
• Patient Weight: 60