MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION

Model Number DGP-PMC-10

Device Problem High impedance (1291)

Patient Problems Burn(s) (1757); No Code Available (3191)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

The grounding pad was discarded and is not available for return.The contract manufacturer indicates that per propriety rights they are not able to provide a device history record.

Event Description

A report was received that the patient was noted as having a blister after an ablation procedure on his calf.It was noted that the impedances were high during the procedure.It was noted that the patient was very hairy.The physician prescribed antibiotics for the blister and or burn.The grounding pad was discarded and is not available for return.The contract manufacturer indicates that per propriety rights they are not able to provide a device history record.

• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): COSMAN MEDICAL, LLC; 22 terry avenue; ,; burlington MA 01803
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8139905
• MDR Text Key: 129568105
• Report Number: 3006630150-2018-62132
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: DGP-PMC-10
• Device Catalogue Number: DGP-PMC-10
• Device Lot Number: 180305-0827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention