MAUDE Adverse Event Report: OSCOR INC. OSCOR TEMPORARY BIPOLAR PACING LEAD 5F; TEMPORARY PACEMAKER ELECTRODE

Model Number 020005

Device Problem Pacing Problem (1439)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.The temporary lead was not returned to perform an analysis.A photo of the device was sent indicating a problem where the lead and the connector meet on the negative pole; however, the photo was not adequate to determine the problem.As the customer indicated the most probable lot number used was dp-02844, the device history record (dhr) for this lot was reviewed.The dhr review identified no rejects during manufacture of this lot.In final packaging there were four (4) rejects for foreign material and two (2) rejects for broken trays.A review of complaints for this lot number found no additional complaints against the lot.The instructions for use (ifu) provide the precaution: avoid kinking or bending the lead to minimize the risk of damage to internal wires.A follow-up report will be sent if additional information becomes available.

Event Description

The customer reported a stimulation problem during use of this temporary lead.The user expressed the problem is located where the lead and the connector meet on the negative pole.The lead was replaced without any reported adverse patient effects from this event.

Manufacturer Narrative

All temporary leads will be inspected 100%.Using multimeter, check the electrical connections (continuity) of each lead.The readings should not exceed 100 ohms.Under magnifying lamp, check lead 100% for any damages, cuts, nicks, cracks, splits, protrusions, etc.In the instructions for use (ifu) the precautions are provided to the user: do not connect to a/c power.Inappropriate connection of exposed pin(s) to an ac power source may pose serious risk of injury or death.The device should be stored at temperatures between 5° c (41° f) and 30° c (86° f).The potential effect to the patient for the reported failure may be related to: lead will lose ability to pace potentially harming the patient.The potential cause for the reported failure may be related to: improper connector crimping.A review of risk for this failure has increased.Based on the investigation information, a corrective and preventive action (capa) has been opened to address this failure.There was no harm to the patient.Oscor will continue to monitor this device for complaint trends and risk.

• Brand Name: OSCOR TEMPORARY BIPOLAR PACING LEAD 5F
• Type of Device: TEMPORARY PACEMAKER ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 5484747
• MDR Text Key: 39839902
• Report Number: 1035166-2016-00027
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K861403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2017
• Device Model Number: 020005
• Device Catalogue Number: 020005
• Device Lot Number: DP-02844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention