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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 11/12/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was being scheduled for emergency surgery. The generator was extruding through the skin. The surgery occurred on (b)(6) 2015 for generator replacement. The extrusion was attributed to the numerous past surgeries the patient experienced at the site of her generator and subsequent scar degradation. The surgeon chose to implant the generator on the right side to avoid aggravating the site of the injury. The explanted generator was discarded after the surgery, so product return and analysis is not possible.

 
Event Description

Clinic notes were received indicating that a patient reported that her generator incision started opening up on approx. (b)(6) 2016 and began to drain. The wound was red and warm but the patient had no fever. A provider evaluated the patient on (b)(6) 2016 and noted she has had some breakdown of the left anterior chest due to several prior vns surgeries. The provider's commentary states that the patient feels the condition is a bit better and the provider notes that there was still some drainage but it had lessened from the time of an evaluation a few days prior. The area was non tender to the touch and there was no sign of fever. The provider concluded that the area was not looking worse and elected to continue oral antibiotics and local wound care. A subsequent visit on (b)(6) 2016 with another provider indicated that no further drainage had occurred. The visit notes indicated that there was a similar amount of induration beneath the skin but no signs of infection. A visit on (b)(6) 2016 with this same provider indicated the patient was still having no further drainage and no change in the induration beneath her skin under her previous incision, nearly identical to her last visit. No further invention was deemed necessary and the provider indicated he only needed to see the patient as necessary. On (b)(6) 2016 the provider reported that the patient had experienced an infection due to her left-sided lead and the patient was referred for removal surgery. No known surgical interventions have occurred to date.

 
Event Description

Review of manufacturing records confirmed sterilization prior to distribution for the lead and all of the generators implanted at the time of the original extrusion event and thereafter. On (b)(6) 2016 the patient underwent removal of her lead and right-sided generator and treatment of her prior left-sided drainage wound. Dense scar tissue was encountered which precluded removal of the lead electrodes. No obvious infection was noted at the site of the right-sided generator. The left chest-wall incision was opened and no obvious infection was encountered and the scarred wall of the previous pocket for the generator was excised in its entirety and sent for culture. The drainage wound which was 3 cm inferior to the left-sided pocket was cultured and excised. No obvious infection was encountered, so the previously planned wound vac was not employed. Attempts to obtain the explanted products for product analysis have been unsuccessful to date.

 
Event Description

The manufacturer was informed that the devices explanted during the (b)(6) 2016 surgery were discarded by the explanting facility.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5275266
Report Number1644487-2015-06632
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup,Followup,Followup
Report Date 11/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/22/2016
Device MODEL Number103
Device LOT Number4042
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/08/2015 Patient Sequence Number: 1
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