MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; 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 05/01/2017

Event Type  Injury  

Event Description

A report was received that the patient's contacts came off of the distal tip of the lead.Fluoroscopy confirmed that contacts are in the subcutaneous tissue and would have to be removed by the surgeon.

Manufacturer Narrative

Sc-2316-50e (b)(4): device evaluation indicated that the complaint was confirmed.Visual inspection revealed distal electrodes #1-#3 were fractured and torn off.Cables are exposed at the separated section of the lead.Electrodes 1-3 were not returned.The cause of the lead damage couldn't be determined.Review of the device history record revealed no anomalies.

Event Description

A report was received that the patient's contacts came off of the distal tip of the lead.Fluoroscopy confirmed that contacts are in the subcutaneous tissue and would have to be removed by the surgeon.

• Brand Name: PRECISION SPECTRA
• 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: 6588480
• MDR Text Key: 75874537
• Report Number: 3006630150-2017-01857
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: (01)08714729797807(17)190323(10)20431419
• 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: 05/01/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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