BIPOL LEAD MODEL 300
Report
- Report Number
- 1644487-2011-00367
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- June 29, 2010
- Report Date
- January 31, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
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CONCLUSIONS: ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
ON (B)(6) 2013, THE PATIENT¿S MOTHER REPORTED THAT IN THE (B)(6) OF 2010, THE PATIENT WENT INTO STATUS WITH LONG PERIODS OF PARTIAL SEIZURES. THE EVENT COULD NOT BE EXPLAINED UNTIL (B)(6) 2010 WHEN THE PATIENT WAS CHECKED IN (B)(6) 2010 AND IT WAS DISCOVERED THAT THE WIRE HAD BECOME DISCONNECTED FROM THE BATTERY.
ON (B)(4) 2013 IT WAS DISCOVERED THAT ON (B)(6) 2010 DIAGNOSTICS HAD BEEN PERFORMED ON THE PATIENT¿S GENERATOR AND THE DCDC WAS 0 INDICATING A POSSIBLE SHORT CIRCUIT. IT WAS REPORTED THAT IT WAS GOING TO BE DIFFICULT OBTAINING AN X-RAY DUE TO THE NATURE OF THE PATIENT¿S DISABILITY. IT WAS STATED THAT THE DEVICE WAS TURNED OFF AND THERE WAS NO PATIENT MANIPULATION OR TRAUMA TO THE DEVICE. THE PATIENT IS NOT ABLE TO PERCEIVE STIMULATION. IT WAS STATED THAT AT THE TIME A ¿WAIT AND SEE APPROACH¿ WAS BEING TAKEN WITH A PLAN TO RE-IMPLANT SHOULD THE PATIENT¿S SEIZURES CONTROL BECOME POOR. IT WAS REPORTED THAT SINCE TURNING THE VNS OFF THE PATIENT WAS ADMITTED TWICE WITH AN INCREASE IN SEIZURES SO IT WAS DECIDED TO TURN BACK ON THE VNS.
ON (B)(6) 2011, IT WAS REPORTED BY A CYBERONICS REGIONAL MANAGER FOR UNITED KINGDOM THAT A VNS PATIENT'S DEVICE WAS EXPLANTED AND REPLACED. FOLLOW UP WITH THE PHYSICIAN REVEALED THAT NO PATIENT MANIPULATION OR TRAUMA WAS REPORTED NOR MEDICATION CHANGES THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PATIENT IS SEVERELY DISABLED THEREFORE, IT IS UNKNOWN IF HE CAN FEEL STIMULATION. THE PHYSICIAN HAD TURNED OFF THE DEVICE DUE TO A SUSPECTED SHORT CIRCUIT CONDITION AND WILL REPLACE THE DEVICE SHOULD SEIZURE CONTROL BECOME POOR. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT WAS ADMITTED TWICE DUE TO INCREASE IN SEIZURES FOLLOWING THE DEVICE BEING TURNED OFF. THE SITE TURNED THE DEVICE BACK ON AS THE PATIENT DID NOT FIT ALL THE CRITERIA FOR A LEAD PROBLEM AND HE SEEMED TO BE WORSE SINCE TURNING IT OFF. PROGRAMMING HISTORY WAS RECEIVED AND REVIEWED AND IT WAS OBSERVED THE SYSTEM DIAGNOSTICS DCDC CODE HAD GONE DOWN FROM 1 TO 0. A SUDDEN DROP ON DCDC CODE WAS NOT VISUALIZED. INCREASE IN SEIZURES WAS RELATED TO THE DEVICE BEING TURNED OFF, THEREFORE, DUE TO LOSS OF VNS THERAPY. THE PATIENT WAS EXPLANTED ON (B)(6) 2011 AND REPLACED WITH A NEW LEAD AND GENERATOR. THE PRODUCT RETURN FORM REPORTED A LEAD BREAK AS THE REASON FOR EXPLANT. THE PHYSICIAN'S NURSE REPORTED THAT THE LEAD BREAK WAS DISCOVERED DURING THE LAST DIAGNOSTICS TEST ON (B)(6) 2010 WHERE THE DCDC CODE WAS FOUND TO BE 0. THE PHYSICIAN DID NOT PERFORM ANY X-RAYS ON THE PATIENT DUE TO THE BEHAVIOUR OF THE PATIENT SO A DEFINITIVE LEAD BREAK WAS NOT VISUALIZED. BASED ON A SUSPECT LEAD BREAK, CYBERONICS ADVISED THE PHYSICIAN TO SWITCH THE GENERATOR OFF. THE EXPLANTED GENERATOR AND 2 PINS OF LEAD WERE RETURNED TO CYBERONICS ON (B)(6) 2011 FOR PRODUCT ANALYSIS. NEITHER ANOMALIES NOR LEAD BREAKS WERE IDENTIFIED WITHIN THE RETURNED LEAD PORTIONS. SINCE A SIGNIFICANT PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION COULD NOT BE MADE ON THAT PORTION OF THE LEAD. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 4758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |