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

Model Number SC-2408-74

Device Problems Fracture (1260); High impedance (1291); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Model number/catalog number: sc-2408-74, serial number: (b)(4), batch/lot number: 20808277, model/catalog description: avista mri perc lead kit 74 cm.

Event Description

A report was received that the patient had a suspected lead fracture.It was also noted that the patient lost coverage due to high impedance.The patient was reprogrammed and most of the pain areas were recaptured.

• Brand Name: AVISTA MRI
• 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: 8110718
• MDR Text Key: 128601255
• Report Number: 3006630150-2018-62000
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: 08714729904823
• Combination Product (y/n): N
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2020
• Device Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 5018388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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: 59 YR