MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1160

Device Problems Overheating of Device (1437); Charging Problem (2892); Wireless Communication Problem (3283)

Patient Problem No Code Available (3191)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred two weeks from the date manufacturer was made aware.

Event Description

It was reported that the patient had to charge the ipg frequently and was unable to get the ipg to a full charge.It was also noted that the ipg was no longer communicating with the remote control (rc) and charging resulted in significant heating up of the ipg.Database analysis revealed no anomalies.It was mentioned that the patient fell directly on the ipg site and the physician suspected that the patients non device related fall had damaged the ipg in some way.The patient underwent a revision procedure wherein the ipg was replaced and was repositioned.The patient was doing well postoperatively.The explanted ipg was discarded.

• Brand Name: SPECTRA WAVEWRITER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10328481
• MDR Text Key: 200580150
• Report Number: 3006630150-2020-03097
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• 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: 07/27/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 347740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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: 46 YR