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

Model Number SC-2316-50E

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2017

Event Type  Injury  

Event Description

A report was received that during patient's trial procedure, the top three contacts of the lead were sheared off and the contacts were left in the epidural space.No further course of action will be taken.The physician believed that the contacts were not causing any harm to the patient.

Event Description

A report was received that during patient's trial procedure, the top three contacts of the lead were sheared off and the contacts were left in the epidural space.No further course of action will be taken.The physician believed that the contacts were not causing any harm to the patient.

Manufacturer Narrative

Model sc-2316-50e (sn:(b)(4)) device evaluation indicated that the lead damage during lead placement has been confirmed.The damage to the lead 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 45º.An angle of more than 45º increases the risk of lead damage.Exposed cables.

Event Description

A report was received that during patient's trial procedure, the top three contacts of the lead were sheared off and the contacts were left in the epidural space.No further course of action will be taken.The physician believed that the contacts were not causing any harm to the patient.

• 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: 6376767
• MDR Text Key: 69029058
• Report Number: 3006630150-2017-00729
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: (01)08714729797807(17)190128(10)20208989
• 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: 02/13/2017

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: Physician
• Device Expiration Date: 01/28/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2017; 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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): Other; Required Intervention
• Patient Age: 66 YR