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

Model Number 97712

Device Problem Pocket Stimulation (1463)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 04/20/2014

Event Type  malfunction  

Event Description

The patient experienced a loss of therapeutic effect.The patient started feeling pain on (b)(6) 2014 and checked his gauge, it had dropped down to 1.0.The patient upped it to 3.0 and that night he felt like he was being burned by cigarettes at the implant site.The patient turned it down but he was still sore.The therapy was not working as expected, there was a change in therapy.It was confirmed that the patient had the stimulation too high.The company representative met with the patient to re-educate him on how to use the system.All is good.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 977a175, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a175, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

• 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: 3811400
• MDR Text Key: 4527965
• Report Number: 3004209178-2014-08976
• 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: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2014
• Date Device Manufactured: 09/06/2013
• 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 Age: 00084 YR