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

Model Number 37713

Event Type  Injury  

Manufacturer Narrative

Main component of the system and other applicable components are: product id 3587a, lot # l94346, implanted: (b)(6) 2003, product type lead; product id 3487a, lot # j0114084v, implanted: (b)(6) 2001, product type lead.

Event Description

Information was received from a patient who was implanted with a neurostimulator for failed back surgery syndrome via a manufacturer representative.It was reported that the patient started having swelling around the implantable neurostimulator pocket and also around the insertion site of one of her leads in the midthoracic area.The patient has pain at the pocket and lead site that is worse at the lead site and the patient was worried that the lead had dislodged and is trying to work its way through the skin.The patient thought that the lead has shifted or ¿came out of the place¿ originally implanted and is causing pain and the patient feels like ¿it is about to come through my skin.¿ the patient denied anything in particular that led to this event.The date that the swelling started to occur is unknown.The patient was referred to the health care provider for a cervical injection, and at that time they discussed the patient not using her stimulator and a possible lead revision and implantable neurostimulator replacement.The patient had not yet had a consult with their health care provider about removing the system, but the patient only expressed a desire to have all components explanted.There was no planned surgical intervention.

Event Description

Additional information received from the manufacturing representative restated that the patient's leads were revised on (b)(6) 2016.However, the patient still had complaints that the leads felt like they were popping through their skin.Upon observation, a small area of edema was noted to the left and below the lead insertion site.It was noted that the leads did not look threatening, or like they were eroding through the skin.The patient mentioned that stimulation felt great post-op, and there were no high impedances reported.

Event Description

Additional information from the manufacturing representative indicated that the patient is tentatively scheduled for a lead revision and possibly a battery replacement.Information was received from the healthcare provider on (b)(6) 2016, stating that the distal ends of the patient's leads were on top of each other at their site of pain.It was noted that the patient's lead extensions were replaced with thinner ones on (b)(6) 2016.The issue has been resolved.

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; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5658592
• MDR Text Key: 45275934
• Report Number: 3004209178-2016-09592
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2007
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/26/2016
• Supplement Dates FDA Received: 10/17/2016; 10/19/2016; 09/22/2017
• Date Device Manufactured: 11/29/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial