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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Complaint, Ill-Defined (2331)

Event Date 10/21/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6)2014, product type: lead.Product id: 97754, serial# (b)(4).Product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

The consumer reported that when they first turned stimulation on after implant, it was too strong and the patient felt vibrations in her leg.It was turned down and the issue was resolved.Additional information received from a healthcare provider (hcp) reported that the cause of the event was not determined and was unknown if it was device related.The patient had not been seen in the healthcare provider's clinic since (b)(6) 2015.It was unknown how the patient was doing.Additional information received from the hcp on (b)(6) 2015 reported that it was still unknown if the cause was device related.The stimulator was removed on (b)(6) 2015.The patient recovered without permanent impairment.It was noted that the patient was implanted for non-malignant pain and failed back surgery syndrome.

• 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: 5059488
• MDR Text Key: 25107147
• Report Number: 3004209178-2015-17398
• 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,health professional
• Reporter Occupation: Other
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• Date Device Manufactured: 03/07/2014
• 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