MAUDE Adverse Event Report: CPI - DEL CARIBE ACUITY; IMPLANTABLE HF LEADS

Model Number	4593
Medical Device Problem Codes	Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Boston scientific received information that this left ventricular (lv) lead had slightly elevated threshold that was noted during device changeout.Boston scientific technical services (ts) discussed options with pacing system analyzer (psa).Additional information received indicating that high threshold was possibly due to micro dislodgement but was not confirmed.There was no action taken.This lv lead remains in service.No adverse patient effects were reported.

• Brand Name: ACUITY
• Common Device Name: IMPLANTABLE HF LEADS
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• MDR Report Key: 7629213
• Report Number: 2124215-2018-11003
• Device Sequence Number: 1432859
• Product Code: LWP
• UDI-Device Identifier: 00802526423222
• UDI-Public: 00802526423222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/28/2013
• Device Model Number: 4593
• Other Device ID Number: ACUITY SPIRAL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0181; 4076; 4136; 4137; 4593; G151; N119; S606
• Patient Age: 75 YR