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

Model Number SC-1132

Device Problems Telemetry Discrepancy (1629); Charging Problem (2892)

Patient Problem Pain (1994)

Event Date 01/17/2017

Event Type  Injury  

Event Description

A report was received that the patient had difficulty charging the ipg and communicating the ipg to the remote control (rc).It was also noted that the patient was experiencing painful stimulation even if the stimulation had been shut off.Database analysis (db) confirmed that there was an issue with the ipg when updating the stimulation parameters after reviewing the fault logs.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that there will be no further course action at this time.

Event Description

A report was received that the patient had difficulty charging the ipg and communicating the ipg to the remote control (rc).It was also noted that the patient was experiencing painful stimulation even if the stimulation had been shut off.Database analysis (db) confirmed that there was an issue with the ipg when updating the stimulation parameters after reviewing the fault logs.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: 6389949
• MDR Text Key: 69437290
• Report Number: 3006630150-2017-00854
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: (01)08714729821526(17)180613(10)19345808
• Combination Product (y/n): N
• 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
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/13/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR