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

Model Number 37712

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 39565-30,serial#: (b)(4), implanted: (b)(6) 2009.Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(4), ubd: 10-mar-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient and healthcare provider (hcp) regarding the patient's implantable neurostimulator (ins) for complex reg.Pain syndrome type i and rsd/causalgia-complex regional pain syn.Information was reported that the patient had both devices removed due to inflammation at their device site.The caller stated the inflammation started seven weeks after their implant, but it was not known which implant date they were referring too.The patient was overheard saying the inflammation got worse, so they removed the devices this march and the patient also had drainage after the devices were removed.There was a confirmed infection, and the patient had a total explant of both systems.The patient is still currently in the hospital to get an emergent mri.The patient said she has a large pocket of fluid on her spine form the surgery she got to remove the inss.The patient said this was going to be her 3rd mri for this issue.The has more than 8 inches of fluid on her spine.No further complications were reported.No additional patient symptoms were reported.

• Brand Name: RESTORE ULTRA
• 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: 8822771
• MDR Text Key: 152079133
• Report Number: 3004209178-2019-14169
• 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,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2010
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 07/24/2019
• Date Device Manufactured: 06/12/2009
• 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): Hospitalization; Required Intervention