MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7426

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 7426, serial# unknown, product type: implantable neurostimulator.(b)(4).

Event Description

The patient's clinician reported via the company representative (rep) a shocking sensation when the implant was off.It was unknown if this was a sudden or gradual change.The patient has not been using the bilateral implantable neurostimulators (ins) and recently reported shocking.The clinician met with the patient yesterday and programmed the patient to 0v and verified system was off.The patient was sent home.Today the patient was still having shocking.It was unknown if the patient has had any recent medical test or emi environmental exposure.The patient was referred to a neurologist to determine if related to their disease state.If additional information is received, a follow up report will be sent.

• Brand Name: SOLETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5021098
• MDR Text Key: 24685328
• Report Number: 3007566237-2015-02342
• 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: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2015
• 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