MAUDE Adverse Event Report: CPI PLANT - ST. PAUL S-ICD SYSTEM

Model Number 3501

Device Problems Defibrillation/Stimulation Problem (1573); Device Dislodged or Dislocated (2923)

Patient Problems Right Ventricular Hypertrophy (2056); Ventricular Tachycardia (2132); Patient Problem/Medical Problem (2688)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

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 an x-ray revealed this electrode had dislodged from it¿s original implant location.A revision procedure was performed utilizing a third incision site and the electrode was successfully repositioned.A 10j shock was delivered which produced an impedance measurement of 70 ohms.The patient was in tachycardia and induction was unsuccessful.No additional adverse patient effects were reported.

• Brand Name: S-ICD SYSTEM
• Manufacturer (Section D): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 8023198
• MDR Text Key: 125596775
• Report Number: 2124215-2018-19239
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: (01)00802526599200(17)20200429
• Combination Product (y/n): N
• PMA/PMN Number: P110042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2020
• Device Model Number: 3501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2018
• 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
• Treatment: 3501; A219
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 127