MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6937A-58
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Impedance Problem (2950)
Health Effect - Clinical Code	Twiddlers Syndrome (2114)
Date of Event	11/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: model: 3116, gastric mgu ipg; implanted: (b)(6) 2012; model: 435135, gastric mgu lead; implanted: (b)(6) 2012; model: 435135, gastric mgu lead; implanted: (b)(6) 2012.
Event or Problem Description
It was reported that the patient phoned in to report that their device had dislodged.Follow-up with the patient's clinic revealed that the patient was seen on (b)(6) and the patient is currently an in-patient at the hospital.It was discovered that the patients right ventricular (rv) lead had triggered a rv lead impedance warning.Via x-ray it was discovered the lead was wrapped around their implantable cardioverter defibrillator (icd) as the pateinet had "twiddled" the device and rotated it within the pocket, therefore dislodging the rv lead.All tachy therapies were programmed "off" at that time.The device and lead currently remain in use and the patient will continue to be monitored until the physician decide how to proceed with the patient's treatment.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRANSVENE CS/SVC
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6320425
• Report Number: 2649622-2017-01629
• Device Sequence Number: 13712409
• Product Code: LWS
• UDI-Device Identifier: 00643169535985
• UDI-Public: 00643169535985
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/11/2018
• Device Model Number: 6937A-58
• Device Catalogue Number: 6937A-58
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: DDBB1D1, ICD / 4968-60, LEAD / 4968-60, LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 84