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

Model Number SC-8216-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Distress (2045); Numbness (2415)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient's device was causing numbness from the armpits to the feet which was messing with the heart rhythm and breathing.It is unknown if the event was device related.

Manufacturer Narrative

Additional information was received that the physician do not believed that the patient¿s heart issue was related to the device.The patient was doing well and no further course of action was necessary.

Event Description

A report was received that the patient's device was causing numbness from the armpits to the feet which was messing with the heart rhythm and breathing.It is unknown if the event was device related.

• 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: 5683865
• MDR Text Key: 46061495
• Report Number: 3006630150-2016-01360
• 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
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2015
• Device Model Number: SC-8216-50
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2013
• 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: 52 YR