MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-8336-50

Device Problems High impedance (1291); Failure to Fire (2610)

Patient Problem No Code Available (3191)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The explanted device was not returned to bsn.A review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient had high impedance.Patient had lost stimulation.The patient underwent a replacement procedure and was doing well postoperatively.

• Brand Name: COVEREDGE 32
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8089733
• MDR Text Key: 127896837
• Report Number: 3006630150-2018-61839
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• 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
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 17781523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR