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

Model Number 7424

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 07/17/2015

Event Type  Injury  

Event Description

The consumer reported that they had a deep brain stimulation device that was used for pain stimulation therapy and it was removed years ago.The patient believed that it was 15 years ago.The patient went in to see his health care provider (hcp) for a check-up and the hcp ¿fiddled with it and he got it cranked up and he couldn¿t shut it down, he was jumping and hopping around from the pain of the shocks.¿ the hcp put the ¿telephone up to his side to program the device.¿ after this was done, an assistant was able to turn the device off.The patient was followed up with a wanted to be left alone as he already reported that the device was taken out.The indication for use (ifu) that is known is pain stimulation therapy.

Manufacturer Narrative

Concomitant products: product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1991, product type: extension.Product id: 3487a, lot# l20847, implanted: (b)(6) 1991, product type: lead.(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: 4976965
• MDR Text Key: 16957710
• Report Number: 1030489-2015-01949
• 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
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• 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: 07/17/2015
• 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