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

Model Number 97702

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

It was reported that the evening of a stimulator replacement, the patient started feeling stimulation go off randomly at varying times.The patient would notice an increase in pain and would then sync to the stimulator.She would see the stimulator off icon and then turn stimulation back on.The patient did not accidentally press the off button.There were no falls or traumas and the device was not programmed for scheduled therapy.It was suggested that the patient keep a log of the instances.Additional information was requested about the cause and outcome.If received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 377845, lot# v012929, implanted: (b)(6) 2006, product type: lead; product id 377845, lot# v012929, implanted: (b)(6) 2006, product type: lead; product id 3708120, serial# (b)(4), implanted: (b)(6) 2006, product type: extension; product id 3708120, serial# (b)(4), implanted: (b)(6) 2006, product type: extension; product id 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Follow up information received confirmed that the patient stated that their stimulation would randomly shut off.It was noted however that they had not had this issue any longer and was getting adequate therapy from their implantable neurostimulator (ins).There was no known reason for their stimulation to turn off without them dong it.The manufacturer's representative reeducated the patient on how to use the remote and how to change programs in case of a user error.The patient was going to contact the representative if the stimulation goes off without them pressing any buttons to turn it off.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: 4119289
• MDR Text Key: 4942679
• Report Number: 3004209178-2014-17748
• 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: 09/04/2014

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: 11/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 09/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/15/2014
• Date Device Manufactured: 05/14/2014
• 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: 00057 YR