MAUDE Adverse Event Report: CYBERONICS, INC.PULSE GEN MODEL 102LYJ

Model Number 102

Event Date 01/01/2007

Event Type  Injury   Patient Outcome  Hospitalization,Life Threatening,Required Intervention

Event Description

Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.

Manufacturer Narrative

Ap and lateral x-ray views of neck and chest evaluated by mfr. No anomalies were noted. Device failure is suspected but did not cause or contribute to permanent impairment or death.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: LYJ
• Manufacturer (Section F): CYBERONICS, INC.; houston TX 77058
• Manufacturer (Section D): CYBERONICS, INC.; houston TX 77058
• Manufacturer Contact: donnie welty, rn, bsn ; 100 cyberonics blvd.; ste. 600; houston , TX 77058; (281) 228 -7200
• Device Event Key: 829510
• MDR Report Key: 842295
• Event Key: 805128
• Report Number: 1644487-2007-00106
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2007

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/20/2007
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: 102
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2007
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes
• Is this an Explanted Device?: No Answer Provided
• Type of Device Usage: Initial