MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number RNS NEUROSTIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Muscle Weakness (1967)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product remains implanted.

Event Description

On (b)(6), 2015: patient was implanted with neuropace rns neurostimulator and two neuropace depth leads (dl-330-3.5-k) and two neuropace cortical strip leads (cl-325-10-k).The lead location are as follows: connected leads cl-325-10-k placed in the left sensory motor region and cl-325-10_k placed in the left inter hemispheric region.There are two depth leads not connected to the neurostimulator and they are placed in the sensory motor cortex and left inter hemispheric region.On (b)(6), 2015: dr.(b)(6), epileptologist reported that patient was complaining of right arm and leg weakness post implant.On (b)(6), 2015: the rns system detection is enabled, stimulation is disabled.The cortical strip lead located in the left sensory motor region was repositioned.On (b)(6), 2015: patient has no history of htn, cardiac disease, prior stroke or hyperlipidemia.Medications at the time of surgery include depakote 1000mcg daily, dilatin 260mg bid and keppra 1500 mg bid.On (b)(6), 2015: patient still notes mild right arm and leg weakness but has noted improvement since the lead was repositioned.The rns system has detection enabled and stimulation disabled.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 6502382788
• MDR Report Key: 4977394
• MDR Text Key: 22377189
• Report Number: 3004426659-2015-00014
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/06/2015

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?: No
• Device Operator: Physician
• Device Model Number: RNS NEUROSTIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 48 YR