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 Device Operates Differently Than Expected (2913)

Patient Problems Foreign Body Reaction (1868); Scar Tissue (2060); Impaired Healing (2378); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 37712 serial# (b)(4) implanted: (b)(6) 2009 explanted: (b)(6) 2011 product type implantable neurostimulator refer to regulatory report # 3004209178-2017-09023.The patient had two implanted systems and it was not clear which issues pertained to which implanted system.The referenced report pertains to the patient¿s other system.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 from a healthcare provider (hcp) regarding a patient who was implanted with two implantable neurostimulators (ins) for failed back surgery syndrome.The hcp reported that the patient had 2 ins¿ and one of them their body rejected and the ins and leads were taken out.The hcp reported that with the second ins where it was implanted, there was a scab/blister that wasn¿t healing so the patient took a pair of scissors, cut it and pulled the ins out as far as it would come and snipped the leads off.The hcp reported that the patient removed the ins through that open wound and cut it off but didn¿t know how much of the leads remained implanted.The hcp reported that the current device was not functioning, but it was unknown what is the ¿current device¿ as it appeared both ins¿ had already been removed.The hcp reported that they had a ct scan that went up as far as the patient¿s lunch from (b)(6) 2016 that showed there were leads still implanted.No further complications reported.Additional information was received from the patient¿s healthcare provider (hcp).It was reported that there was no battery pack (implantable neurostimulator, ins) in the patient at the time of the call.The hcp stated that only the remaining leads were still in the patient.It was noted that the patient¿s leads were mri compatible.It was unknown who the patient¿s managing hcp was and the caller had no further information.No further complications were reported.

Manufacturer Narrative

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

• 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: 6520055
• MDR Text Key: 73630999
• Report Number: 3004209178-2017-09026
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2010
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Date Device Manufactured: 05/11/2009
• 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): Required Intervention