MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number U128

Device Problem High impedance (1291)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

A boston scientific technical services consultant documented and discussed the clinical observations with the caller.The consultant stated that as long as the measurements were appropriate in the programmed vector, it was acceptable.The caller stated that a fluoroscopy was not performed and therefore, the root cause of the clinical observations could was not determined.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this system exhibited a pacing impedance measurement of greater than 3000 ohms in one configuration and 450 ohms in another configuration.It was noted that this patient has clostridium difficile (c-diff).No adverse patient effects were reported.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT PUERTO RICO BV
• Manufacturer (Section G): GUIDANT PUERTO RICO BV
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6464531
• MDR Text Key: 72129136
• Report Number: 2124215-2017-03559
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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