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

Model Number 7426

Device Problem Malposition of Device (2616)

Patient Problems Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted.After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well.The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side.On the same day the patient¿s healthcare professional adjusted the target position of the right ins.Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well.On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse.The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve.Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy.No interventions or outcome were reported regarding this event.Additional information could not be obtained.Should additional information be received the event will be updated.Refer to manufacturer report #3004209178-2014-18342.

Manufacturer Narrative

Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator.(b)(4).

• Brand Name: SOLETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4144132
• MDR Text Key: 17164203
• Report Number: 3007566237-2014-02852
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 10/06/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 00045 YR