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

Model Number 1007283

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The implanted rns system consists of the following rns-300, sn (b)(4), implanted (b)(6) 2013.Cl-325-10k, sn (b)(4), 101292 implanted (b)(6) 2005.Dl-344-10-k, sn (b)(4), implanted (b)(6) 2005.Cl-325-10, sn (b)(4), implanted (b)(6) 2005.

Event Description

The rns system including the neurostimulator, ferrule and leads were all explanted on (b)(6) 2016 after patient's incision failed to heal properly after an attempt at a wound revision.The incision continued to show signs of wound dehiscence and therefore the decision was made to remove all product.Upon removal of the leads, the surgeon noted that a portion of the insulation on one of the leads was not present.It was not clear what lead this was as the surgeon opted not to open the craniotomy to remove the electrode portion of the leads and will do so when the patient is re-implanted at a later date.All product has been returned to neuropace for further analysis.

• 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: 5540962
• MDR Text Key: 41649424
• Report Number: 3004426659-2016-00008
• 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
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1007283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 42 YR