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

Model Number 97714

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 03/12/2015

Event Type  Injury  

Event Description

The patient experienced stimulation in the wrong location and pain in left lower leg.Stimulation/therapy issues was reported.Reprogramming was noted.The lead was going to be moved down to cover the lower part of his left leg, was currently only covering the upper part of his leg.The lead was in the incorrect location.During the revision the doctor accidently removed the lead from the space and was not able to place it back into the proper location.The lead was permanently removed.During the revision the patient was tapped twice which further complicated intra op testing.The lead that remained implanted was moved more midline.After the procedure the patient was having inconsistent responses about the location of the stimulation.The physician will follow up with the patient in a couple weeks.Implanting physician may discuss the possibility of a lami lead at that time.Additional information has been requested to find out the outcome of this event.If additional information is received, a follow up report will be sent.Reference manufacturer report # 3004209178-2015-06008.

Manufacturer Narrative

Concomitant: product id 977a260, serial# (b)(4), implanted: 2014-(b)(6), explanted: 2015-(b)(6), product type lead.Product id 977a260, serial# (b)(4), implanted: 2014-(b)(6), product type lead.Product id 977a260, serial# (b)(4), implanted: 2014-(b)(6), explanted: 2015-(b)(6), product type lead.Product id 97754, serial# (b)(4), product type recharger.Product id 977a275, serial# (b)(4), implanted: 2014-(b)(6), product type lead.Product id 3550-29, lot# n304210, implanted: 2014-(b)(6), product type accessory.Product id 97754, serial# (b)(4), product type recharger.Product id 97740, serial# (b)(4), product type programmer, patient.Product id 97714, serial# (b)(4), implanted: 2014-(b)(6), product type implantable neurostimulator.Product id 977a260, serial# (b)(4), implanted: 2014-(b)(6), product type lead.Product id 977a275, serial# (b)(4), implanted: 2014-(b)(6), product type lead.(b)(4).

• 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 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: 4661965
• MDR Text Key: 21059245
• Report Number: 3004209178-2015-06017
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2015

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: 06/14/2015
• 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: 03/12/2015
• Initial Date FDA Received: 04/06/2015
• Date Device Manufactured: 07/17/2014
• 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): Required Intervention
• Patient Age: 00069 YR