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

Model Number SC-1132

Device Problem Telemetry Discrepancy (1629)

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

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that the patient¿s ipg would not link to the remote control during a lead revision procedure.The ipg was linked to the remote control prior to the procedure.It was noted that electrocautery was used in the lead site, but not on the ipg itself.The physician ended up replacing the ipg.The ipg was suspected of being compromised during the procedure.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

Device evaluation indicated that the ipg would not be charged due to damaged u2 and u3 asics.As a result, it would not be linked.The device exhibited excessive sleep current leakage.Hot spots were observed on both components.The impedance between vh and ground was low.These are the typical symptoms of the asic damage due to exposure to high-voltage transients, causing internal shorts in the components.It was reported that electrocautery was used during the revision procedure.

Event Description

A report was received that the patient's ipg would not link to the remote control during a lead revision procedure.The ipg was linked to the remote control prior to the procedure.It was noted that electrocautery was used in the lead site, but not on the ipg itself.The physician ended up replacing the ipg.The ipg was suspected of being compromised during the procedure.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 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: 5677576
• MDR Text Key: 45854929
• Report Number: 3006630150-2016-00988
• 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: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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: 56 YR