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

Model Number SC-1110-02

Device Problems Device Inoperable (1663); Charging Problem (2892)

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

Event Date 05/04/2018

Event Type  Injury  

Event Description

A report was received that the patients ipg was non-functional. The patient will undergo a revision procedure.

Manufacturer Narrative

Additional information was received that the patients ipg was using more battery power and was charging frequently. The patient will undergo an ipg replacement procedure.

Event Description

A report was received that the patients ipg was non-functional. The patient will undergo a revision procedure.

Manufacturer Narrative

Additional information was received that there will be no further course of action at this time. A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing. A review of the sterilization documentation for the device was found to be satisfactory.

Event Description

A report was received that the patients ipg was non-functional. The patient will undergo a revision procedure.

• 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: 7547834
• MDR Text Key: 109351334
• Report Number: 3006630150-2018-01867
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/11/2014
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/28/2018 Patient Sequence Number: 1