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

Model Number SC-2218-50

Device Problems Fracture (1260); Kinked (1339); Impedance Problem (2950)

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

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A report was received that the patient had a suspected lead fracture.It was noted that the area of the generator showed a possible kink in the wires and the distal part of the leads looked pinched together which is believed to be the cause of the lead fracture.The patient will undergo a lead revision procedure.

Manufacturer Narrative

Additional information was received that the patients leads had bad impedances.The patient underwent a lead replacement procedure and 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 leads revealed that no anomalies or deviations potentially related to the event occurred during the manufacturing.

Event Description

A report was received that the patient had a suspected lead fracture.It was noted that the area of the generator showed a possible kink in the wires and the distal part of the leads looked pinched together which is believed to be the cause of the lead fracture.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: 7575558
• MDR Text Key: 110295798
• Report Number: 3006630150-2018-02009
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2016
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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: 82 YR