MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ITREL II; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7424

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

Patient Problems Pain (1994); Skin Erosion (2075); Swelling (2091); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Fluid Discharge (2686)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components: product id: 3888-28, lot# l30355, implanted: (b)(6) 1992, explanted: (b)(6) 1995, product type: lead.

Event Description

Information was received from a patient implanted with an implantable neurostimulator (ins).The patient reported that the area around where the lead protruded swelled up like a blister and popped.It was stated that the lead was actually out of the skin.The patient indicated it was not infected.The patient was scheduled for surgery the next day ((b)(6) 2016 to have about four inches of the lead removed).It was reviewed with the patient that the explants full or partial were medical decisions.

Manufacturer Narrative

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

Additional information received from the patient indicated that there were no circumstances that led to the event.One day the patient got up and a wire was sticking out of the leg with some drainage.So they went to a surgeon and he removed part of the wire.After that, the wire was sticking out more and the patient had several days of pain and drainage.Now the surgeon wants to remove the whole device.

Manufacturer Narrative

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

• Brand Name: ITREL II
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5937150
• MDR Text Key: 54264243
• Report Number: 6000032-2016-00121
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

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 Model Number: 7424
• Device Catalogue Number: 7424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided; 12/19/2016
• Supplement Dates FDA Received: 01/10/2017; 09/29/2017
• 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: 57 YR