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

Model Number 97714

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Date 03/17/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The healthcare professional (hcp) of a clinical study reported that there was lead migration/dislodgement.The clinical diagnosis was a loss of pain coverage.The outcome was ongoing.Interventions included reprogramming the entire system.The event resulted in an unscheduled clinic or office visit.The patient reported that when the device was placed she had adequate coverage and felt that she was getting good coverage in both lower extremities, but at the time of report she did not feel that was the case.The patient reported that programming was unsuccessful and paresthesia was uncomfortable and still did not cover the painful areas.Imaging showed that there was migration anteriorly of one of the patient's eads.The etiology was reported as related to the device or therapy and not related to the implant procedure.The etiology was reported as related to the leads which were connected to the implantable neurostimulator (ins).Relevant medical history: spinal pain.

Event Description

Additional information received reported the leads were explanted and replaced on (b)(6) 2016.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the outcome was resolved without sequelae.The patient reported that the current spinal cord stimulator (scs) programming was very effective in relieving her pain.

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 was received from a health care provider (hcp) via a manufacturer representative (rep).It was reported that the cause of the lead migration was unknown.No other information was provided.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5875858
• MDR Text Key: 52099380
• Report Number: 3004209178-2016-16826
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Date Device Manufactured: 12/15/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR