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

Model Number SC-1132

Device Problems Telemetry Discrepancy (1629); Device Displays Incorrect Message (2591); Charging Problem (2892); Data Problem (3196)

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

Event Date 08/15/2017

Event Type  malfunction  

Event Description

A report was received that the patient was having issues with charging.It was noted that the ipg was having communication difficulties with the remote control (rc).Upon connecting with the clinicians programmer, an error code occurred that related to data corruption on the ipg.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Sc-1132 (b)(4) device evaluation indicated that the complaint was confirmed.Upon receiving, the device was able to link to a test remote control, and the battery level showed 3.8 volts.However, the charge and system data logs were corrupted, and the device failed on the functional test.It was due to the intermittent battery internal resistance resulted from the battery tab anomaly.The defective battery was the source of the charging and communication anomalies.

Event Description

A report was received that the patient was having issues with charging.It was noted that the ipg was having communication difficulties with the remote control (rc).Upon connecting with the clinicians programmer, an error code occurred that related to data corruption on the ipg.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure.Device malfunction was suspected and the patient was doing well postoperatively.

Event Description

A report was received that the patient was having issues with charging.It was noted that the ipg was having communication difficulties with the remote control (rc).Upon connecting with the clinicians programmer, an error code occurred that related to data corruption on the ipg.The patient will undergo an ipg replacement 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: 7007989
• MDR Text Key: 91919890
• Report Number: 3006630150-2017-04403
• 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,Followup,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• 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: 77 YR