MAUDE Adverse Event Report: ST. JUDE MEDICAL PERMANENT DEFIBRILLATOR ELECTRODES; PUL GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD1411-36Q

Device Problems Break (1069); Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Date 07/15/2019

Event Type  No Answer Provided  

Event Description

Dear medwatch, i'm writing you, asking for our assistance, on (b)(6) 2021 one of mv leads broke off mv defibrillator.I'm trying to find out what device i have.The dr, who put it in now saying i have a single chamber device.I was given this medical document that shows multiple numbers.If you could make out any sense of this.Please send me a photo copy of the device in question.I filed a lawsuit, now i am in fear of having the dr who put it in - now pull it out, but it's poking me and hurting me.S/p implantation of automatic cardioverter / defibrillator (aicd): per ucsd notes, ip has a st jude medical crmd ellipse vr model # cd1411-36q device implanted in left chest wall on (b)(6) 2019.Serial number is (b)(4).Icd lead: he has st jude medical-crmd optisure lda210q-65 lead implanted in the right ventricular apex on (b)(6) 2019 with serial no: (b)(4).Last interrogation normal on (b)(6) 2019, needs f/u in 6 months.History of long qt., s/p icd 2007 in (b)(6) but removed in 2014 due to recall.No replacement device was re-implanted at the time.Seen by (b)(6) 2019 and found to have retained icd wires.Ip underwent removal of residual icd wires with implantation of new icd device (b)(6) 2019 removed in 2014, lead removal.

• Brand Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: PUL GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 12217113
• MDR Text Key: 263474476
• Report Number: MW5102727
• Device Sequence Number: 2
• Product Code: NVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/10/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR