MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL LLC SUBDERMAL NEEDLE ELECTRODE; ELECTRODE, NEEDLE

Model Number	RLSND121-2.5
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Hospital reports that a needle has broken off in a patient.The report was submitted to rhythmlink quality through rhythmlink sales dept by phone.

• Brand Name: SUBDERMAL NEEDLE ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL LLC; columbia SC 29209
• MDR Report Key: 8174684
• Report Number: MW5082190
• Device Sequence Number: 1902676
• Product Code: GXZ
• UDI-Device Identifier: 10816312020141
• UDI-Public: (01)10816312020141
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: RLSND121-2.5
• Device Catalogue Number: RLSND121-2.5
• Device Lot Number: P000009937
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention