MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEOTECH; NEOLEAD

Lot Number NOT PROVIDED

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.Patient information and date of event were requested, unavailable at the time of this report.

Event Description

The customer reported that they were provided new leads.When they removed the leads from the baby, there was a mark/burn on the skin.Philips is in the process of finding out what type of emergency care was provided.

Manufacturer Narrative

The customer reported they were provided new leads by philips for demonstration purposes.When the customer removed the leads from the patient, there was a mark/burn on the skin.Calcium arginate was applied as treatment.No long-term effects were reported.One (b)(4) micro neolead radio lead was returned to (b)(6) for evaluation.The date code could not be confirmed.The lot code is located on the package which was discarded.Visual inspection of the leads found they were in good condition with no evident defects.Using a digital volt meter found the leads were not shorted together and working without any problems.The customer removed the leads from the patient, there reportedly was a mark/burn on the skin.Calcium arginate was applied as treatment.No long-term effects were reported.We are considering that, if the customer required a new lead wire, they purchased one.The returned material was scrapped after the evaluation was completed.Although the exact cause of the mark/burn could not be identified.There were no defects with the electrode as it functioned correctly.It possible the cause was a reaction to the adhesive on the electrode.

• Brand Name: NEOTECH
• Type of Device: NEOLEAD
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6792587
• MDR Text Key: 82627747
• Report Number: 1218950-2017-05631
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

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
• Device Operator: Health Professional
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/14/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 DA
• Patient Weight: 1