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

Model Number SC-2218-50E

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

Patient Problems Nerve Damage (1979); Paralysis (1997); Numbness (2415)

Event Date 03/07/2017

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 the explanted devices were not returned to bsn as it were discarded by the medical facility. It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the trial patient was experiencing numbness, soreness, and stinging in both hands and right foot. The physician turned off the device which resolved the right foot. It was noted that the physician felt that the leads were rubbing against the patient¿s nerve root causing paresthesia in both hands and some nerve root irritation causes some swelling in the patient¿s right shoulder. The patient underwent a revision procedure wherein the leads were explanted.

• 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: 6433329
• MDR Text Key: 70856919
• Report Number: 3006630150-2017-01068
• 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

• Type of Report: Initial
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/06/2018
• Device Model Number: SC-2218-50E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/24/2017 Patient Sequence Number: 1