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U.S. Department of Health and Human Services

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

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MDT SOFAMOR DANEK PUERTO RICO MFG ITREL II; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
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.
 
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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 Key5937150
MDR Text Key54264243
Report Number6000032-2016-00121
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
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 Number7424
Device Catalogue Number7424
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/16/2016
Initial Date FDA Received09/08/2016
Supplement Dates Manufacturer ReceivedNot provided
12/19/2016
Supplement Dates FDA Received01/10/2017
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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