MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV

Device Problems Fracture (1260); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Defibrillation/Stimulation Problem (1573); Low impedance (2285); Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Additional information received from the patient noted that this patient received a shock.Technical services was contacted and referred the patient to the physician for further follow up.At this time the system remains implanted.

Event Description

Additional information provided noted that the patient had been sleeping next to an electrical riser which caused the increase in noise episodes.Technical services could not discount the possible electromagnetic interference but noted that myopotentials created noise, and the atp delivered is likely not associated with the electromagnetic interference source.A possible issue with the lead was discussed.At this time the system remains implanted.

Event Description

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Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information received noted that pocket stimulation resulting in oversensing was also observed when it comes to this case.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory visual inspection revealed trilumen insulation abraded though the rate/sense negative coils.In addition setscrew marks were noted on the terminal pin.The lead underwent and passed electrical testing.Laboratory analysis concluded exposed conductors approximately 24.5 cm from the is-1 terminal pin.Due to the location and type of damage it is likely this was caused by entrapment in the clavicle/first rib region.

Event Description

Boston scientific received information that the patient claimed that she was feeling therapy being delivered while driving.The therapy was alleged to be anti tachycardia therapy.A review of the episodes appeared to be myopotential and electromagnetic interference.Upon interrogation of the device artifacts were seen on the right ventricular and right atrial lead.A review of the data was set to technical services for review.No adverse patient effects were reported.

Manufacturer Narrative

A review of the date by technical services noted noise only on the right ventricular channel with inappropriate anti tachycardia therapy delivered.In addition it was noted that the right ventricular lead showed a single out of range low pacing impedances measurement as well as low intrinsic amplitudes earlier in (b)(6) 2015.At this time the system remains implanted.

Event Description

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Manufacturer Narrative

(b)(4).Additional information received noted that this lead was explanted and insulation damage was confirmed upon explant.No additional adverse patient effects were reported.The product is expected to be returned for analysis.This report will be updated upon return and completion of the analysis.

Event Description

Additional information was provided inquiring regarding warranty on a fractured right ventricular lead.At this time the system remains implanted.

Manufacturer Narrative

(b)(4).

• 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 55112 ; 6515824786
• MDR Report Key: 4653371
• MDR Text Key: 5605141
• Report Number: 2124215-2015-01101
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/07/2015; 04/08/2015; 04/09/2015; 04/09/2015; 04/09/2015; 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0295; 4136; F111
• Patient Age: 32 YR