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 08/14/2015

Event Type  malfunction  

Event Description

A report was received that the patient's remote control (rc) was experiencing telemetry issues when communicating with the ipg.A bsn representative analyzed the database and revealed that the ipg exhibited signs of a high internal resistance battery.It confirmed a possible defect.An ipg replacement was recommended.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure.It was not certain if the ipg was malfunctioning.The patient was reportedly doing well postoperatively.

Event Description

A report was received that the patient's remote control (rc) was experiencing telemetry issues when communicating with the ipg.A bsn representative analyzed the database and revealed that the ipg exhibited signs of a high internal resistance battery.It confirmed a possible defect.An ipg replacement was recommended.

Manufacturer Narrative

Sc-1132 (sn (b)(4)): device evaluation indicated that the source of the telemetry anomaly was due to intermittent internal resistance of the battery.Upon receiving the device was able to communicate with a test remote control.However, the measurement of the battery internal resistance found intermittent reading varying from 2.9155 ohms to open.The complete battery and system data logs were not read due to corrupted address of the data the firmware holds as the result of preexisting battery failures.The battery was sent to the vendor (quallion) for further root cause analysis.

Event Description

A report was received that the patient's remote control (rc) was experiencing telemetry issues when communicating with the ipg.A bsn representative analyzed the database and revealed that the ipg exhibited signs of a high internal resistance battery.It confirmed a possible defect.An ipg replacement was recommended.

• 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: 5067871
• MDR Text Key: 25411181
• Report Number: 3006630150-2015-02271
• 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: Followup,Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: SC-1132
• Other Device ID Number: M365SC11320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2015; 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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: 41 YR