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

Model Number SC-1110-02

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date (b)(6) 2013 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Model number/catalog number: sc-8216-50, serial number: (b)(4), batch/lot number: 16211315, model/catalog description: artisan lead 50 cm.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patients stimulator became disconnected.The patient underwent an explant procedure.No further information could be obtained.

• Brand Name: PRECISION
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 9313383
• MDR Text Key: 166323717
• Report Number: 3006630150-2019-06457
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2013
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 14794555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2011
• 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
• Patient Age: 51 YR