MAUDE MDR 5380560

MDR report key: 5380560
Report number: MW5059405
Event key: 0
Event type: 3
Date of event: 2015-11-27
Date received: 2016-01-15
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 500
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	SUBDERMAL NEEDLE ELECTRODES	SUBDERMAL NEEDLE ELECTRODES	RHYTHMLINK INTERNATIONAL, LLC	GXZ	SAP320609	RLSND 122-2.5					*	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2016-01-15	0	1. R

Event Narratives#

D

Patient 1

A NEEDLE FROM A NEUROMONITORING PROBE BROKE OFF INTRA-OPERATIVELY IN THIS PATIENT'S LEFT LOWER ARM REQUIRING REMOVAL AFTER LOCALIZING WITH X-RAY.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
08720791375140	Neuroguard	Technomed Engineering B.V.	GXZ	2026-06-05
08720791375164	Neuroguard	Technomed Engineering B.V.	GXZ	2026-06-05
08720791370732	Cadwell	Technomed Engineering B.V.	GXZ	2023-10-09
08720791370862	Ambu	Technomed Engineering B.V.	GXZ	2023-09-29
08720791370893	Ambu	Technomed Engineering B.V.	GXZ	2023-09-29
08720791370817	Ambu	Technomed Engineering B.V.	GXZ	2023-09-29
08720791372026	Technomed Europe	Technomed Engineering B.V.	GXZ	2023-08-01
08720791370909	Ambu®	Technomed Engineering B.V.	GXZ	2023-07-11
08720791370930	Ambu®	Technomed Engineering B.V.	GXZ	2023-07-11
08720791370961	Ambu®	Technomed Engineering B.V.	GXZ	2023-07-11
08720791370992	Ambu®	Technomed Engineering B.V.	GXZ	2023-07-11
08720791371456	Intech	Technomed Engineering B.V.	GXZ	2023-06-23
08720791371371	CNS - Premier Vision	Technomed Engineering B.V.	GXZ	2023-06-01
08720791371395	CNS - Premier Vision	Technomed Engineering B.V.	GXZ	2023-06-01
08720791371418	CNS - Premier Vision	Technomed Engineering B.V.	GXZ	2023-06-01
08720791371432	CNS - Premier Vision	Technomed Engineering B.V.	GXZ	2023-06-01
08720791371067	AD-TECH	Technomed Engineering B.V.	GXZ	2023-02-16
08720791370206	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370220	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370527	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370541	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370565	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370589	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370657	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370671	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370695	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370718	Neuroguard	Technomed Engineering B.V.	GXZ	2023-01-02
08720791370770	Neurosign	Technomed Engineering B.V.	GXZ	2022-12-07
08720791370268	Neuroguard	Technomed Engineering B.V.	GXZ	2022-09-28
08720791370282	Consolidated Neuro Supply	Technomed Engineering B.V.	GXZ	2022-09-28

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K241045	GXZ	Disposable Subdermal Needle Electrode, Corkscrew	Technomed Europe	2024-12-11
510(k)	K232581	GXZ	Medical Disposable Sterile Needle Electrode	Suzhou Haishen Medical Device Associates Co., Ltd.	2023-12-04
510(k)	K231691	GXZ	Phantom XL Insulated Dilators	TeDan Surgical Innovations, Inc.	2023-06-29
510(k)	K200984	GXZ	Guardian Needle Electrode	Rhythmlink International, LLC	2020-05-27
510(k)	K192603	GXZ	Spes Medica Subdermal Needle Electrodes	Spes Medica Srl	2019-11-22

MAUDE MDR 5380560

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#