MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	LDA230Q/65
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Twiddlers Syndrome (2114)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.(b)(4).
Event or Problem Description
It was reported that patient presented during follow-up in-clinic.Upon review, the patient left ventricular(lv) lead exhibited loss of capture.A chest x-ray revealed that the lv lead was wrapped around the patient's implantable cardioverter defibrillator(icd).During the lv lead revision procedure, the physician noticed the right ventricular(rv) was wrapped around the icd as well and the leads had tangled together.The physician described the incident as twiddler's syndrome.Both the lv and rv leads were replaced.The patient was discharged.Related manufacturer reference number: 2017865-2019-06374.
Additional Manufacturer Narrative
The damage found was sustained during the surgical procedure.The lead was otherwise normal.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
New information received stating that dislodgement was noted on the left and right ventricular leads.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8576351
• Report Number: 2017865-2019-06375
• Device Sequence Number: 13862617
• Product Code: NVY
• UDI-Device Identifier: 05414734507394
• UDI-Public: 05414734507394
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2019

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: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: LDA230Q/65
• Device Lot Number: S000030037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 09/03/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 08/23/2019; 09/13/2019
• 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: QUICKFLEX MICRO
• Patient Age: 73 YR