NEUROPACE RNS SYSTEM
Report
- Report Number
- 3004426659-2017-00055
- Event Type
- Injury
- Date Received
- December 6, 2017
- Date of Event
- September 29, 2017
- Report Date
- July 12, 2018
- Manufacturer
- NEUROPACE, INC.
- Product Code
- PFN
- UDI-DI
- 00855547005045
- PMA / PMN Number
- P100026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THE REVIEW OF THE PATIENT ECOG AND IMPEDANCE DATA WAS CONSISTENT WITH A POTENTIAL LEAD BREAK.
(B)(4). THE EXPLANTED LEAD WAS RETURNED FOR INVESTIGATION. LEAD COIL DAMAGE WAS CONFIRMED; HOWEVER NEUROPACE WAS UNABLE TO DETERMINE THE ROOT CAUSE.
IN EARLY (B)(6) 2017, A SUSPECTED LEAD BREAK WAS DIAGNOSED BY THE TREATING EPILEPTOLOGIST. IMPEDANCE MEASUREMENTS DISPLAYED "INSUFFICIENT CHARGE" ON LEAD 2. THERE WAS NO CHANGE IN THERAPY. NO INFORMATION WAS PROVIDED BY THE TREATING CENTER WHETHER THE PATIENT HAD UNDERGONE ANY HEAD TRAUMA IN THE AREA OF THE LEAD EXITING THE SKULL. ON (B)(6) 2017 THE AFFECTED LEAD WAS REPLACED AS IT HAD CONTINUED TO SHOW HIGH IMPEDANCES. DURING THE PROCEDURE THE NEUROSURGEON DID NOT OBSERVE ANY VISIBLE ABNORMALITIES AT THE LEAD-CONNECTOR COVER INTERFACE OR AT THE SKULL ENTRY POINT WHERE THE LEAD WAS ANCHORED WITH A CUT LEAD CAP AND A DOG BONE. THE NEWLY IMPLANTED DEPTH LEAD SHOWED GOOD IMPEDANCES AND NORMAL ECOG READINGS, AND THE LEAD ISSUE WAS CONSIDERED RESOLVED. THE EXPLANTED LEAD HAS NOT YET BEEN RETURNED TO NEUROPACE, INC.
PRODUCT EVALUATION PERFORMED ON RETURNED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867974 | NEUROPACE RNS SYSTEM | NEUROPACE RNS SYSTEM | PFN | NEUROPACE, INC. | DL-330-10-K | 22147-1-1-1 | 00855547005045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization |