MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Fever (1858); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 12/18/2013

Event Type  Injury  

Event Description

It was reported that the atrial fibrillation (afib) procedure for this patient was on (b)(6) 2013.This procedure was completed without complications.On (b)(6) 2014, the bwi field representative was notified that this patient was readmitted to the hospital several days ago.On (b)(6) 2014, the patient had an endoscopy procedure which confirmed an esophageal fistula.Upon request, additional information was provided on the event.The patient was readmitted on (b)(6) 2014.The event was life threatening.The damage was severe.The patient presented with a stroke, temperature and pericarditis.The patient was in the icu in critical condition with maximal drips to maintain his blood pressure.His status was critical.The physician¿s opinion regarding the causality was that it was possibly device related.The procedure was pulmonary vein isolation (pvi).

Manufacturer Narrative

Evaluation summary.Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4).Coolflow pump, model #: m-5491-02, serial #: (b)(4).Non-bwi medtronic quad.Non-bwi bard coronary sinus catheter.(b)(4).

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that the atrial fibrillation (afib) procedure for this patient was on (b)(6) 2013.This procedure was completed without complications.The patient was readmitted on (b)(6) 2014.On (b)(6) 2014, the patient had an endoscopy procedure which confirmed an esophageal fistula.The event was life threatening.The damage was severe.The patient presented with a stroke, temperature and pericarditis.The patient was in the icu in critical condition with maximal drips to maintain his blood pressure.His status was critical.The physician¿s opinion regarding the causality was that it was possibly device related.The stockert unit (b)(4) was tested and no issues were found during the evaluation.The unit was in calibration and is operating fine with no issues.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3584159
• MDR Text Key: 4190289
• Report Number: 9612355-2014-00005
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR