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

Model Number SC-2218-50

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2014

Event Type  Injury  

Event Description

A repot was received that during a revision procedure, it was discovered that part of the lead separated.The damage to the lead occurred prior to the revision.The lead was explanted.

Event Description

A repot was received that during a revision procedure, it was discovered that part of the lead separated.The damage to the lead occurred prior to the revision.The lead was explanted.

Manufacturer Narrative

Device evaluation indicated that a cable was exposed right where the lead was sutured.It appeared that the exposed cable was pulled and it resulted in the damaged lumen.The root cause of the cable exposure was unknown.Additionally, visual inspection revealed the lead was clean cut approximately 14 inches from the distal end.The proximal portion of the lead was not returned.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.The lead damage has been confirmed.

• 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: 4190638
• MDR Text Key: 4985546
• Report Number: 3006630150-2014-02411
• Device Sequence Number: 1
• Product Code: LGW
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

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: 11/01/2014
• Device Model Number: SC-2218-50
• Other Device ID Number: M365SC2218500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 10/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2012
• 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: 78 YR