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

Model Number SC-1140

Device Problem Telemetry Discrepancy (1629)

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

Event Date 03/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that during patient's lead revision procedure, the remote control would not connect with the ipg.The physician confirmed that he may have hit the ipg with the electrocautery.The ipg was replaced and the patient was doing well postoperatively.Monopolar electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of monopolar electrocautery.(physician's implant manual 9055940-001).

Manufacturer Narrative

Sc-1140 sn: (b)(4).Device evaluation indicated that the device passed all tests performed.The complaint was not verified.The ipg was linked with a test novi remote control without any issue.The device functional test was performed to ensure the device integrity.No anomalies were found.

Event Description

A report was received that during patient's lead revision procedure, the remote control would not connect with the ipg.The physician confirmed that he may have hit the ipg with the electrocautery.The ipg was replaced and the patient was doing well postoperatively.Monopolar electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of monopolar electrocautery.(physician's implant manual 9055940-001).

• Brand Name: PRECISION®
• 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: 5542986
• MDR Text Key: 41719401
• Report Number: 3006630150-2016-00745
• Device Sequence Number: 1
• Product Code: LGW
• 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: 03/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/07/2016
• Device Model Number: SC-1140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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 Age: 52 YR