MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ITREL II; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7424

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Arthritis (1723); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported the patient had developed cancer and needed radiation treatment and guidelines were requested.The patient hadn¿t used the device in years and they hadn¿t used it since they received a letter in 1994.They turned it off because it was ¿wearing out their nerves, like they used it too much.¿ they started to get real bad arthritis about 5 or 6 years after they started to use it all of the time.One time it had turned on by itself.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3586, serial# (b)(4), implanted: (b)(6) 1992, product type: lead.Product id: 7496-51, serial# (b)(4), implanted: (b)(6) 1992, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: ITREL II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4243809
• MDR Text Key: 4993116
• Report Number: 6000032-2014-00270
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 12/23/2014
• 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 Age: 00041 YR