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

Model Number 37714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead.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

The healthcare professional (hcp) of a clinical study reported that the device diagnosis was not applicable.The clinical diagnosis was side effects following implant.The outcome was resolved without sequelae.Interventions included caffeine supplements, lidoderm patch, and hydroxizine.Interventions included explanting and not replacing the device.The event resulted in an unscheduled clinic or office visit.The patient reports hypotension, dizziness, itching, increased hypersensitivity of the right lower extremity, and increased nerve pain without pain relief since initial implant.The etiology was noted as possibly related to the device or therapy and possibly related to the implant procedure.The etiology was noted as due to stimulation.The etiology was noted as surgery/anesthesia.The etiology was noted as related to the implantable neurostimulator (ins).Relevant medical history included: spinal pain.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the clinical diagnosis was worsening pain following implant consistent with cord tethering.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5588579
• MDR Text Key: 43155791
• Report Number: 3004209178-2016-07796
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Date Device Manufactured: 08/23/2015
• 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: 00030 YR