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

Model Number RNS-320-K

Device Problems Premature Discharge of Battery (1057); Dent in Material (2526); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Product received (b)(6) 2020.(b)(4).The explanted product was returned to neuropace for analysis.Upon receipt, neuropace confirmed that the device was at end of service and that a large physical dent was present on the top of the device.The returned device is currently undergoing additional analysis.

Event Description

On (b)(6) 2020 neuropace field personnel were conducting a routine review of the patient's rns neurostimulator data on pdms.At that time it was identified that the device was at end of service (eos), potentially indicating a premature battery depletion which was communicated to the treating clinician.The rns neurostimulator was replaced on (b)(6) 2020, at which time it was reported by the neurosurgeon that a visual review of the explanted device showed that it was physically dented.Further discussion with the family revealed that the patient had fallen from a ladder several times around the date the battery depletion occurred.

Event Description

The explanted device was returned to neuropace and investigated.

Manufacturer Narrative

(b)(4) investigation of the returned device identified that the rapid battery depletion was caused by a sustained increased in battery load.The increased load was a result of damage to internal device components sustained when the device was crushed (described in the initial report as a "large physical dent").Damage to the device occurred when the patient fell off the ladder and hit his head where the neurostimulator was implanted.

• Brand Name: NEUROPACE RNS SYSTEM
• Type of Device: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• MDR Report Key: 10522272
• MDR Text Key: 207152854
• Report Number: 3004426659-2020-00041
• Device Sequence Number: 1
• Product Code: PFN
• UDI-Device Identifier: 00855547005267
• UDI-Public: 010085554700526717190821
• Combination Product (y/n): N
• PMA/PMN Number: P100026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RNS-320-K
• Device Catalogue Number: 1007694
• Device Lot Number: 26562-1-1-1
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR