* MSC-PI 134 LEK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-25 for * MSC-PI 134 LEK manufactured by Microrecording Systems Consultants.

Event Text Entries

[250436] During deep brain stimulator placement (therapy for tremor) micro electrode brain mapping was performed. Recordings with first electrode were successful. Micro stimulation was conducted. This required that a new electrode be used for subsequent recording. A new electrode was inserted. Pt complained of severe intracranial pain (surgery is done under local anesthesia). Electrode was removed immediately. Although marked with same catalog # the second electrode was incorrectly too long (228 mm). Correct length was 188 mm. Pt had no untoward effects. Issue resolved with mfr.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025721
• MDR Report Key: 408451
• Date Received: 2002-07-25
• Date of Report: 2002-07-23
• Date of Event: 2002-07-11
• Date Added to Maude: 2002-08-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: MICROELECTRODE
• Product Code: MUV
• Date Received: 2002-07-25
• Returned To Mfg: 2002-07-18
• Model Number: *
• Catalog Number: MSC-PI 134 LEK
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 397441
• Manufacturer: MICRORECORDING SYSTEMS CONSULTANTS
• Manufacturer Address: 981 N HUDSON AVE PASADENA CA 91104 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: MICROELECTRODE
• Product Code: GZL
• Date Received: 2002-07-25
• Returned To Mfg: 2002-07-18
• Model Number: *
• Catalog Number: MSC-PI 134 LEK
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 397512
• Manufacturer: MICRORECORDING SYSTEMS
• Manufacturer Address: 981 N. HUDSON AVE PASADENA CA 91104 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-07-25