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

Model Number SC-1110

Device Problem Device Stops Intermittently (1599)

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

Event Date 05/11/2017

Event Type  malfunction  

Event Description

A report was received that the patient¿s ipg turned off on its own.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.The patient was doing well post operatively.

Event Description

A report was received that the patient¿s ipg turned off on its own.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Sc-1110-02 (b)(4) device evaluation indicated that the device passed all tests performed.

Event Description

A report was received that the patient¿s ipg turned off on its own.The patient will undergo an ipg replacement 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: 6606515
• MDR Text Key: 76481993
• Report Number: 3006630150-2017-02070
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: SC-1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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