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

Model Number SC-8336-50

Device Problems Bent (1059); Material Separation (1562)

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

Event Date 08/01/2017

Event Type  Injury  

Event Description

A report was received that during an implant procedure, one of the contacts had bent up but still intact into the lead that was placed in the cervical canal confirmed by fluoroscopy.However, it looks like it came out of the setting.The patient underwent a revision procedure wherein the lead was replaced.

Manufacturer Narrative

Sc-8336-50 (sn:(b)(4)) the complaint has been confirmed.Visual inspection revealed the distal electrode #5 is partially dislodged but still attached to their respective cable.No exposed cables.A dhr review confirmed that no anomalies were detected during manufacturing and inspection.

Event Description

A report was received that during an implant procedure, one of the contacts had bent up but still intact into the lead that was placed in the cervical canal confirmed by fluoroscopy.However, it looks like it came out of the setting.The patient underwent a revision procedure wherein the lead was replaced.

• 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: 6810191
• MDR Text Key: 83230303
• Report Number: 3006630150-2017-03086
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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: 08/01/2017

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: 12/14/2018
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2007
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2016
• 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: 43 YR