MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37713

Device Problems Break (1069); Use of Incorrect Control/Treatment Settings (1126); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Erythema (1840); Pain (1994); Dizziness (2194); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 05/27/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3708340; serial# (b)(4); implanted: (b)(6) 2005; product type: extension.Product id 3708340; serial# (b)(4); implanted: (b)(6) 2005; product type: extension.Product id 389233; serial# (b)(4); implanted: (b)(6) 2003; product type: lead.Product id 389233, serial# (b)(4); implanted: (b)(6) 2003; product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative (rep) on 2017-06-19.The rep reported that the x-rays sho wed potential lead movement.The rep reported that the physician planned on going in on (b)(6) 2017 to explore lead movement.No further complications were reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 3708340; serial# (b)(4); implanted: (b)(6) 2005; product type: extension.Product id 3708340; serial# (b)(4); implanted: (b)(6) 2005; product type: extension.Product id 389233; serial# (b)(4); implanted: (b)(6) 2003; product type: lead.Product id 389233, serial# (b)(4); implanted: (b)(6) 2003; product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative (rep) on 2017-06-19.The rep reported that the x-rays sho wed potential lead movement.The rep reported that the physician planned on going in on (b)(6) 2017 to explore lead movement.No further complications were reported.

Manufacturer Narrative

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

• Brand Name: RESTORE ADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6650078
• MDR Text Key: 77938309
• Report Number: 3004209178-2017-13154
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842367
• UDI-Public: 00613994842367
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Date Device Manufactured: 07/16/2013
• 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: 74 YR
• Patient Weight: 77