MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97702

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Low impedance (2285)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/10/2014

Event Type  malfunction  

Event Description

It was reported that the patient¿s stimulator was replaced due to normal depletion.A new device was placed with an adaptor and impedances were out of range.Electrodes 0/3 were less than 150 ohms.Post operatively, combinations using electrodes 0, 1, 2 had impedances ranging from 4,914 ohms to 6,986 ohms.The patient had no stimulation post operatively, even at 10.5v.Multiple combinations were tried.The company representative planned to let the device settle and test again soon.It was further reported that the patient had not been seen as of (b)(6) 2014.Stimulation had not been turned on.The plan was to run another impedance test at the next appointment.If additional information is obtained, a follow up report will be sent.

Event Description

It was further reported by the patients physician that as of (b)(6) 2014, the battery still was not working.

Manufacturer Narrative

Concomitant products: product id neu_unknown_lead, lot# unknown, product type lead; product id neu_unknown_ext, serial# unknown, product type extension.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 3790008
• MDR Text Key: 4386461
• Report Number: 3007566237-2014-01230
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2014

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 Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 05/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2014
• 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 Age: 00055 YR