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

Model Number SC-2316-50E

Device Problems Break (1069); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/25/2017

Event Type  Injury  

Event Description

A report was received that during trial procedure, resistance was noted during the insertion of the lead.A couple of contacts remained in the patient's body when the physician tried to pull it back out from the skin and needle.Lead broke was also noted.

Manufacturer Narrative

Additional information was received that the patient had a successful trial and there were no contacts left inside the patients body.There will be no further course of action to be taken.(b)(4) device evaluation indicated that visual inspection found that electrodes # 1, 2 were missing from distal end of lead and the cables were exposed.This kind of anomaly is consistent with the damages done to a lead when the orientation of the insertion needle¿s bevel is facing down or the angle of the insertion needle is greater than 45 degree.An angle of more than 45 degree increases the risk of lead damage.

Event Description

A report was received that during trial procedure, resistance was noted during the insertion of the lead.A couple of contacts remained in the patient's body when the physician tried to pull it back out from the skin and needle.Lead broke was also noted.

• 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: 6948426
• MDR Text Key: 89282313
• Report Number: 3006630150-2017-03978
• 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
• Report Date: 11/17/2017

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: Lay User/Patient
• Device Expiration Date: 08/26/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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