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

Model Number 97714

Device Problem Failure to Deliver Energy (1211)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 05/07/2014

Event Type  Injury  

Event Description

It was reported that the patient did not have stimulation sensation.The patient couldn¿t get the stimulator to turn on and stated it was like it had gone dead.The patient synced and stated he was on group a/upright, even though he was sitting down.Stimulation was on at 4.10 but the patient did not feel stimulation in his legs.He had increased it all the way up to 8 and was not feeling any stimulation.The patient hadn¿t been feeling stimulation for quite a long time.The patient had back operations on 2014 (b)(6) and 2014 (b)(6) and stimulation had not been turned on since he came back from the hospital the week prior.The patient now had discomfort in his legs and his physician suggested he turned the stimulator back on to help.The patient had not felt stimulation since the first surgery on 2014 (b)(6).Additional information was requested, if received a follow up report will be sent.

Manufacturer Narrative

Product id 3777-60, serial# (b)(4), implanted: 2011 (b)(6);product type lead product id 3777-60, serial# (b)(4), implanted: 2011 (b)(6); product type lead.(b)(4).

Event Description

Additional information received from the patient reported the ins and lead wires were replaced on 2015 (b)(6).The patient turned the stimulation off since (b)(6) 2014 and the device was dormant until replacement 2 weeks ago.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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4021428
• MDR Text Key: 17618399
• Report Number: 3004209178-2014-15548
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2015
• Date Device Manufactured: 12/06/2013
• 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: 00055 YR