MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 39565-30 lot# serial# (b)(4) implanted: (b)(6) 2008 explanted: (b)(6) 2017 product type lead product id 3708140 lot# serial# (b)(4) implanted: (b)(6) 2008 explanted: (b)(6) 2017.Product type extension product id 3708140 lot# serial# (b)(4) implanted: (b)(6) 2008 explanted: (b)(6) 2017.Product type extension.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for failed back surgery syndrome and spinal pain and degenerative disc disease.It was reported a multi lead trialing cable (mltc) was used to check impedances on a lead and extensions.The readings on electrodes 4-15 were "invalid" and had readings over 20,000 ohms.When the lead and extensions were removed on (b)(6) 2017, and replaced with a lead, then the impedance test results were normal.The explanted lead and extensions were discarded by the customer.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative (rep).The high impedances were found from performing an impedance check.A rep saw the patient and programmed around the invalid electrodes.The patient totally recovered from the replacement surgery.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep).It was reported the rep did not remember when they met with the patient.The rep stated they remember one electrode read high, but they were able to get good stimulation coverage in the patient¿s low back and legs with new programming.The rep did not attend the patient¿s follow up appointments and more answers would have been discovered at the patient¿s revision.No further complications were reported.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6926119
• MDR Text Key: 88822512
• Report Number: 3004209178-2017-21285
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Date Device Manufactured: 01/16/2016
• 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