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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616)

Patient Problems Chest Pain (1776); Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.The following codes apply to lead 977a260, serial number (b)(4).(b)(4).

Event Description

The patient reported via the manufacturer representative (rep) experiencing pain/ uncomfortable stimulation in the thoracic space on the left side from the spine around to sternum.It was unknown what may have led to the issue.There were no claimed falls; the patient claimed to have been resting.The patient was out-processing from the army and was not working.An impedance check was done and impedances were found to be normal.A fluoroscopic check of the right lead still showed at the t7-8 interspace.The left lead was now resting at the bottom of t1.The physician ordered and viewed the live fluoroscopy.The rep was able to program pain relief with the existing lead at t7-8 for the lower left leg.The lead resting at t1 was taken out of programming.A lead revision was scheduled for this wednesday, (b)(6) 2016, at 7:30 a.M.Indication for use included lumbar radiculopathy and spinal pain.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative reported that the lead resting at the bottom of t1 had not migrated any further.The outcome of the lead revision was positive, in that it had resolved the issue of pain/uncomfortable stimulation in the thoracic space on the left side from the spine around to the sternum and the patient had adequate pain relief/pain coverage following the revision surgery.

Manufacturer Narrative

Section references the main component of the device other applicable components are: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2016 explanted: product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer.The patient reported that at the time of the event he thought he was having heart attach or chest paint.The patient stated that the issue started a month after implant and after trouble shooting the patients healthcare provider determined that the patient stimulator had slipped.The patient stated they had surgery in (b)(6) 2016 which resolved the issue at the time.No further complications were reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5661001
• MDR Text Key: 45365796
• Report Number: 3004209178-2016-09669
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2017
• Date Device Manufactured: 02/11/2016
• 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