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

Model Number 97714

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was further stated that the left lead was removed and replaced due to the no stimulation and high impedances.After the lead was replaced, intraoperative and post operative impedances were normal with both an external neurostimulator and the sensor implantable stimulator.No issues were identified intra operatively and the lead was discareded.The post operative coverage was good and included all painful areas.The patient was receiving effective therapy.No additional testing was done or was planned.

Event Description

It was reported that the patient had a loss of stimulation in his left leg and a loss of therapeutic effect.The patient had less than 50% therapy relief.This was noted to be related to the left side implant.Electrodes 8-15 had impedances greater than 10,000 ohms.A revision was not scheduled yet.The device was reprogrammed.Xrays were also done.The patient¿s status was alive with no injury.It was further reported that the patient was still waiting to be scheduled for a revision as of (b)(6) 2014.Additional information was requested, if received a follow up will be sent.

Manufacturer Narrative

Concomitant products: product id 977a260, serial # (b)(4), implanted: (b)(6) 2013, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2013, product type lead; product id 97754, serial # (b)(4), product type recharger; product id 97740, serial # (b)(4), product type programmer, patient.(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: 3867332
• MDR Text Key: 4494747
• Report Number: 3004209178-2014-11440
• 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,Followup
• Report Date: 05/20/2014

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 Expiration Date: 07/14/2014
• 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: 06/19/2014
• Initial Date FDA Received: 06/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2014
• Date Device Manufactured: 08/14/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00065 YR