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

Model Number 97714

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Skin Erosion (2075); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Product id 97740, serial# (b)(4); product type programmer, patient product id 977a190, serial# (b)(4), implanted: 2014 (b)(6); product type lead product id 97754, serial# (b)(4); product type recharger product id 977a190, serial# (b)(4), implanted: 2014 (b)(6); product type lead product id 977a190, serial# (b)(4), implanted: 2014 (b)(6); product type lead.(b)(4).

Event Description

It was reported that the patient had complications develop and it was determined that one of the leads had slipped from its original position.In october, the leads punctured the skin in his neck, becoming exposed.On an emergency basis, the entire system was removed.The physician felt the failure was due to the lack of scar tissue forming around the leads, allowing the slippage to occur.The patient was discussing the possibility of a new implant after a 6 months healing period, potentially with a paddle lead.The patient was redirected to their physician.Additional information was requested from the patients physician about this event.If 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: 4298818
• MDR Text Key: 19372606
• Report Number: 3004209178-2014-22629
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2014
• Date Device Manufactured: 01/21/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 00060 YR