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

Model Number SC-1110-02

Device Problem Device Inoperable (1663)

Patient Problem Respiratory Distress (2045)

Event Date 03/25/2016

Event Type  Injury  

Manufacturer Narrative

Udi= (b)(4).

Event Description

A report was received that the patient's ipg was no longer working.The patient underwent an ipg replacement procedure.During the procedure, the patient had respiratory issues and was sent to post-anesthesia care unit (pacu).The patient was reportedly doing well.

Manufacturer Narrative

Additional information was received that device malfunction was not suspected.It was also reported that the patient's respiratory issues were not device related.The explanted device was not returned to bsn.

Event Description

A report was received that the patient's ipg was no longer working.The patient underwent an ipg replacement procedure.During the procedure, the patient had respiratory issues and was sent to post-anesthesia care unit (pacu).The patient was reportedly doing well.

• 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: 5712537
• MDR Text Key: 47104027
• Report Number: 3006630150-2016-01470
• 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
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR