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

Model Number SC-2218-50

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2218-50 serial#:( b)(4) description: linear st lead, 50cm model#: sc-2352-50 serial#: (b)(4) description: linear 3-4 lead, 50cm.

Event Description

A report was received that the patient was experiencing pain and burning sensation after a motor vehicle accident.It was noted that the leads had been damaged and dislodged causing the burning sensation in the upper area each time the scs was turned on.Device was not malfunctioning.The physician suspected that the leads had migrated.The patient will undergo a lead replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a lead replacement procedure.The patient was doing well postoperatively.The explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices 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 pain and burning sensation after a motor vehicle accident.It was noted that the leads had been damaged and dislodged causing the burning sensation in the upper area each time the scs was turned on.Device was not malfunctioning.The physician suspected that the leads had migrated.The patient will undergo a lead replacement 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: 7264015
• MDR Text Key: 99825337
• Report Number: 3006630150-2018-00500
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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: 03/19/2018

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: 06/22/2018
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/28/2018
• Supplement Dates FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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: 51 YR