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

Model Number SC-2218-50E

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

Patient Problem Reaction (2414)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2218-50e serial #: (b)(4) description: trial linear st lead, 50cm.

Event Description

A report was received that the patient was experiencing allergic reaction from the medication given after the trial procedure.Symptoms of itching and bumps in her right arm.The bsn representative was not sure if it was a standard medication.The patient was given an unknown treatment.

Manufacturer Narrative

Additional information was received that the medication given to the patient was a standard postoperative medication.The patient was switched to another medication.

Event Description

A report was received that the patient was experiencing allergic reaction from the medication given after the trial procedure.Symptoms of itching and bumps in her right arm.The bsn representative was not sure if it was a standard medication.The patient was given an unknown treatment.

• 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: 7106702
• MDR Text Key: 94466190
• Report Number: 3006630150-2017-05022
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729784067
• UDI-Public: 08714729784067
• 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: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2019
• Device Model Number: SC-2218-50E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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: 46 YR