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 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

The explanted device was not returned to bsn as it was kept by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient¿s ipg had difficulty connecting to the remote control (rc).It was noted that the patient had a previous lead revision procedure wherein electrocautery was used.The physician suspected that electrocautery caused the ipg to malfunction.The patient underwent an ipg replacement procedure and was reportedly doing well postoperatively.Electrocautery is a known source of high voltage transient signal and current company labeling warns against the use of electrocautery.(physician¿s implant manual 90970880-04).

• 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: 6778056
• MDR Text Key: 82601971
• Report Number: 3006630150-2017-02895
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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 Age: 54 YR