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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Dizziness (2194); Discomfort (2330)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported the therapy was not changing with positions.The patient woke up in the morning with a terrible back ache and dizziness on (b)(6) 2016; he checked the implantable neurostimulator (ins) and it showed 2.60v.The patient lowered the amplitude and felt better within 30 minutes.Prior to the symptoms, the patient had lowered the amplitude to 0.8v and waited 3 minutes for the change to stay.The group with adaptivestim (as) was turned on.The patient programmer (pp) displayed the correct position.The correct amplitude was shown for the current position.Stimulation was comfortable in the position the patient needed.During the report the patient tried to increase/decrease the amplitude, but he pressed the sync partway through so stimulation was not at the level he needed it.The patient tried again, and the change remained after changing positions back and forth after syncing.The indication for use included failed back surgery syndrome and non-malignant pain.Additional information has been requested to find out more information regarding this event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the consumer reported that the initial settings were too high for them.After lowering them from 2.6 to.8 the soreness resolved.The patient stated that they now know that they can't move for three minutes after making an adjustment.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 5380261
• MDR Text Key: 36651566
• Report Number: 3004209178-2016-00773
• Device Sequence Number: 1
• Product Code: LGW
• 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: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Date Device Manufactured: 02/17/2015
• 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: 00062 YR