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

Model Number 97714

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3487a-33, lot# j0519248v, implanted: (b)(6) 2005, product type: lead.Product id: 3487a-33, lot# j0519418v, implanted: (b)(6) 2005, product type: lead.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

A consumer implanted for non-malignant pain and post-herpetic neuralgia reported about two months ago they had a gradual return of pain in their right under arm and across their right breast that was getting worse.The consumer also noticed a knot that appeared in their upper spine which affected more pain especially leaning back on any surface.It was further reported on (b)(6) 2016 an x-ray was performed which showed the lead tips were at the top of t1 and t2 so it was determined the leads moved (although there were no previous x-rays to compare to so it was unknown if lead migration had occurred).There were no traumas or falls reported related to the issue.The manufacturers representative (rep) performed an impedance test which showed electrodes 1, 3, and 7 had results greater than 20,000 ohms.The rep.Was able to change the programming to recapture the left arm pain which the consumer was go ing to try for a month with the understanding they may need a lead replacement at some point if the new programming didnt help their pain.However, the consumer also reported they were told they would have to the leads readjusted or have new leads put in.It was unknown if the issue was currently resolved or if surgical intervention was planned.As of november 7, 2016 the consumer reported the new programming they received helped somewhat, but it wasnt much better so their pain and other issues hadnt been resolved.

Manufacturer Narrative

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 healthcare provider (hcp) reported the consumer was scheduled for a revision to have their device replaced because it wasn¿t ¿working correctly.¿ no further complications were reported/anticipated.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6102169
• MDR Text Key: 59868481
• Report Number: 3004209178-2016-23971
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 03/15/2017

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: 09/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided; 02/20/2017
• Supplement Dates FDA Received: 03/15/2017; 09/27/2017
• Date Device Manufactured: 10/17/2013
• 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: 82 YR