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

Model Number SC-2317-50

Device Problems Kinked (1339); Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2317-50 serial#: (b)(4) description: infiniontm cx 50 cm lead.

Event Description

A report was received that the patient was experiencing worsening pain on the left side traveling down the left leg due to lead migration.X-ray showed epidural stimulator leads project over the posterior spinal canal extending from the t7 level.It was also reported that the patient was having mechanical complications of the lead.The patient will undergo a lead revision procedure.

Manufacturer Narrative

Additional information was received that the reason for revision was the patient not getting adequate coverage due to lead migration.

Event Description

A report was received that the patient was experiencing worsening pain on the left side traveling down the left leg due to lead migration.X-ray showed epidural stimulator leads project over the posterior spinal canal extending from the t7 level.It was also reported that the patient was having mechanical complications of the lead.The patient will undergo a lead revision procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected this was not due to manufactures air somehow, the lead was kinked any impedances occurred.The patient was doing well postoperatively.The explanted device was not returned to bsn as it was kept by the medical facility.A review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient was experiencing worsening pain on the left side traveling down the left leg due to lead migration.X-ray showed epidural stimulator leads project over the posterior spinal canal extending from the t7 level.It was also reported that the patient was having mechanical complications of the lead.The patient will undergo a lead revision procedure.

• 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: 7240992
• MDR Text Key: 98999615
• Report Number: 3006630150-2018-00305
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: 08714729861614
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2018
• Device Model Number: SC-2317-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2016
• 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: 80 YR