MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2218-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); No Code Available (3191)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2016 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Model number/catalog number: sc-2218-50, serial number: (b)(4), batch/lot number: 14193814, model/catalog description: linear st lead kit 50 cm.Model number/catalog number: sc-1110-02, serial number: (b)(4), batch/lot number: 14160128, model/catalog description: precision ipg kit.

Event Description

A report was received that the wires were irritating the patient.The patient underwent an explant procedure.

Manufacturer Narrative

Additional information was received that no further information could be obtained.

Event Description

A report was received that the wires were irritating the patient.The patient underwent an explant procedure.

• Brand Name: LINEAR ST
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8791820
• MDR Text Key: 151087127
• Report Number: 3006630150-2019-03561
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2013
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 14193814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention