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

Model Number 97702

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

When the patient lays down, her stimulation was uncomfortable.The device was implanted for pain in both legs and hips.The device was adjusted today.Just prior to reporting, when the patient laid down the stimulation went ¿so fast¿ it was uncomfortable.When the patient laid down the first time she had stimulation at 7.50.During the report the patient turned the stimulation off then to 0v.The patient turned the stimulation back on and increased to 6.50v then tried laying down and the same thing happened.The patient tried decreasing to 3.8v and the same thing happened.It was confirmed that the adaptivestim (as) was not turned on.The patient turned the stimulation off but the pain came back in her legs.The stimulation was turned back on but down to 0v and she could still feel stimulation in her legs.The patient was waiting to hear back from a company representative.Additional information has been requested to find out if any troubleshooting or intervention was required and the outcome of the event.If additional information is received, a follow up will be sent.

Event Description

Additional information received reported the patient received assistance from their healthcare professional or a manufacturing representative and their concerns were resolved.The patient had an appointment on (b)(6) 2014.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.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.(b)(4).

• 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: 4204235
• MDR Text Key: 4978567
• Report Number: 3004209178-2014-20468
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Date Device Manufactured: 02/20/2014
• 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 Age: 00081 YR