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

Model Number 97712

Device Problems Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 11/09/2014

Event Type  malfunction  

Event Description

The patient experienced stimulation/therapy issues, stimulation in the wrong location.The patient was not feeling stimulation as high in her head as she previously did.The patient fell saturday night.There was less than 50% therapy relief at the lead location.Reprogramming occurred as a result of the event.Diagnostic testing or troubleshooting was not performed but will be performed in the future.The patient¿s doctor was updated and the patient was to make a follow up appointment with her doctor in a month.Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Product id: 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a290, 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 product id: 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

The company representative reported over a month later that the patient received additional reprogramming and was informed to call if it was not effective.The company representative has not heard from the patient since the reprogramming session.

• 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: 4298764
• MDR Text Key: 5084168
• Report Number: 3004209178-2014-22627
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2014
• Date Device Manufactured: 06/11/2014
• 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: 00036 YR