MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RLSND121-2.5; SUBDERMAL NEEDLE ELECTRODE

Model Number	RLSND121-2.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that a technician removed the lead from the patient, the needle was detached from the lead, and the needle remained in the patient's skin.The customer stated the product was rlsnd121-2.5, but was unsure of the lot number (pm00020288 or pm00020061).

• Brand Name: RLSND121-2.5
• Common Device Name: SUBDERMAL NEEDLE ELECTRODE
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first street south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 first street south; columbia, SC 29209 ; 6783341720
• MDR Report Key: 14654295
• Report Number: 1067162-2022-00003
• Device Sequence Number: 4918903
• Product Code: GXZ
• UDI-Device Identifier: 10816312020141
• UDI-Public: (01)10816312020141
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: RLSND121-2.5
• Device Catalogue Number: RLSND121-2.5
• Device Lot Number: PM00020288 OR PM00020061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown