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); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 07/20/2014

Event Type  Injury  

Event Description

The company representative confirmed that the patient was programmed in recovery and she had 100% coverage of her pain.

Event Description

It was reported the patient had a loss of stimulation and therapeutic effect.It was noted the patient was reprogrammed, but coverage could not be extended to the right knee.It was reported the patient had stimulation in the right foot only.It was noted impedance testing was performed.It was reported the patient had less than fifty percent therapy relief in the knee.It was noted the patient had right knee coverage after implant, but lost coverage the next morning.It was reported the change may be associated with the patient reaching down to put their socks on.It was noted the patient¿s pain increased.It was reported the x-ray showed the lead had migrated one vertebra.It was noted the migrated lead was not used in programming.It was reported reprogramming again did not resolve the issue.It was reported a revision was performed.It was noted the anchor and sutures were intact on the migrated lead.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient had an mri of the l-spine.Per a healthcare provider (hcp) it was not related to the device, but a manufacturing representative (rep) reported that the mri was to find the source of persistent lower limb pain and problems from the patient's two surgeries; initial lead placement and revision.There was reflex sympathetic dystrophy; neuralgia; neuritis; and pain in the joint, lower leg, and limb.It was unknown when these issues started.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4005869
• MDR Text Key: 4898488
• Report Number: 3004209178-2014-15228
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2014

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: 03/14/2015
• 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: 02/03/2015
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/09/2014; 02/25/2015
• Date Device Manufactured: 04/15/2014
• 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: 00017 YR