MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

Model Number SC-2316-50E

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/04/2017

Event Type  Injury  

Event Description

A report was received that during the patients scheduled lead pull, six contacts of the trial lead remained in the patients body and was confirmed via x-ray.The patient will undergo a procedure where in the contacts will be removed.

Manufacturer Narrative

Additional information was received that no further course of action will be taken.

Event Description

A report was received that during the patients scheduled lead pull, six contacts of the trial lead remained in the patients body and was confirmed via x-ray.The patient will undergo a procedure wherein the contacts will be removed.

Manufacturer Narrative

Additional information was received that the patient underwent an explant procedure.

Event Description

A report was received that during the patients scheduled lead pull, six contacts of the trial lead remained in the patients body and was confirmed via x-ray.The patient will undergo a procedure wherein the contacts will be removed.

• Brand Name: PRECISION
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7147009
• MDR Text Key: 95789645
• Report Number: 3006630150-2017-05224
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• 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,Followup,Followup
• Report Date: 03/26/2018

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: Lay User/Patient
• Device Expiration Date: 05/20/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 02/02/2018; 03/07/2018
• Supplement Dates FDA Received: 02/07/2018; 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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: 69 YR