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

Model Number SC-1110-02

Device Problems Failure to Charge (1085); Telemetry Discrepancy (1629)

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

Event Date 02/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that the patient's ipg would not charge, would not connect to the remote control and would not function.It was noted that the patient had a medical condition and was defibrillated multiple times and underwent a non-device related procedure where all kinds of electrocautery was used.The patient underwent an ipg replacement procedure.Device malfunction was suspected either due to multiple defibrillation and or electrocautery used.The patient was doing well postoperatively.

Event Description

A report was received that the patient's ipg would not charge, would not connect to the remote control and would not function.It was noted that the patient had a medical condition and was defibrillated multiple times and underwent a non-device related procedure where all kinds of electrocautery was used.The patient underwent an ipg replacement procedure.Device malfunction was suspected either due to multiple defibrillation and or electrocautery used.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-1110-02 (sn (b)(4)) device evaluation indicated that the complaint was confirmed.The ipg generated a continuous beeping sound when a charger was placed on the ipg.Internal inspection confirmed that vh node was shorted to the case node (zero ohm), and ground (zero ohm).This symptom indicated that analog ic-u1 had been damaged.Exposing the ipg to high voltage transients can cause this type of failure.(ref: (b)(4)).It was reported that the patient was defibrillated multiple times.

Event Description

A report was received that the patient's ipg would not charge, would not connect to the remote control and would not function.It was noted that the patient had a medical condition and was defibrillated multiple times and underwent a non-device related procedure where all kinds of electrocautery was used.The patient underwent an ipg replacement procedure.Device malfunction was suspected either due to multiple defibrillation and or electrocautery used.The patient was doing well postoperatively.

• Brand Name: PRECISION®
• 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: 5723488
• MDR Text Key: 47341718
• Report Number: 3006630150-2016-01520
• 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,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2010
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2009
• 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: 65 YR